CARDIOVASCULAR
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Ordering information is available below for coronary guide wires, organized by category.

Coronary Workhorse Guide Wires

HI-TORQUE BALANCE™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE BALANCE™ 28000-HC 3 cm Straight Hydrophilic 190 cm
HI-TORQUE BALANCE™ 28000J-HC 3 cm J Hydrophilic 190 cm
HI-TORQUE BALANCE™ 28001-HC 3 cm Straight Hydrophilic 300 cm
HI-TORQUE BALANCE™ 28000 3 cm Straight Hydrophobic 190 cm
HI-TORQUE BALANCE™ 28000J 3 cm J Hydrophobic 190 cm
HI-TORQUE BALANCE™ 28001 3 cm Straight Hydrophobic 300 cm

HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001780-HC 3 cm Straight Hydrophilic 190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001780J-HC 3 cm J Hydrophilic 190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001782-HC 3 cm Straight Hydrophilic 300 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001782J-HC 3 cm J Hydrophilic 300 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001780 3 cm Straight Hydrophobic 190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001780J 3 cm J Hydrophobic 190 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001782 3 cm Straight Hydrophobic 300 cm
HI-TORQUE BALANCE MIDDLEWEIGHT™ 1001782J 3 cm J Hydrophobic 300 cm

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009660 3 cm Straight Hydrophilic 190 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009660J 3 cm J Hydrophilic 190 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009661 3 cm Straight Hydrophilic 300 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009661J 3 cm J Hydrophilic 300 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009662 3 cm Straight Hydrophilic 190 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009662J 3 cm J Hydrophilic 190 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009663 3 cm Straight Hydrophilic 300 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL™ 1009663J 3 cm J Hydrophilic 300 cm No Marker

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009664 3 cm Straight Hydrophilic 190 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009664J 3 cm J Hydrophilic 190 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009665 3 cm Straight Hydrophilic 300 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009665J 3 cm J Hydrophilic 300 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009666 3 cm Straight Hydrophilic 190 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009666J 3 cm J Hydrophilic 190 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009667 3 cm Straight Hydrophilic 300 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II™ 1009667J 3 cm J Hydrophilic 300 cm No Marker

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011880 3 cm Straight Hydrophilic 190 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011880J 3 cm J Hydrophilic 190 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011881 3 cm Straight Hydrophilic 300 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011881J 3 cm J Hydrophilic 300 cm Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011882 3 cm Straight Hydrophilic 190 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011882J 3 cm J Hydrophilic 190 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011883 3 cm Straight Hydrophilic 300 cm No Marker
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE™ 1011883J 3 cm J Hydrophilic 300 cm No Marker

HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE BALANCE HEAVYWEIGHT™ 1000462H 4.5 cm Straight Hydrophilic 190 cm
HI-TORQUE BALANCE HEAVYWEIGHT™ 1000462HJ 4.5 cm J Hydrophilic 190 cm
HI-TORQUE BALANCE HEAVYWEIGHT™ 1000463H 4.5 cm Straight Hydrophilic 300 cm
HI-TORQUE BALANCE HEAVYWEIGHT™ 1000463HJ 4.5 cm J Hydrophilic 300 cm

HI-TORQUE FLOPPY II™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE FLOPPY II™ 22339H 2 cm Straight Hydrophilic 190 cm
HI-TORQUE FLOPPY II™ 22339M 2 cm Straight Hydrophobic 190 cm
HI-TORQUE FLOPPY II™ 22339MJ 2 cm J Hydrophobic 190 cm
HI-TORQUE FLOPPY II™ 22359M 2 cm Straight Hydrophobic 300 cm
HI-TORQUE FLOPPY II™ 22359MJ 2 cm J Hydrophobic 300 cm
HI-TORQUE FLOPPY II™ 22339M-903 30 cm Straight Hydrophobic 190 cm
HI-TORQUE FLOPPY II™ ES 22299H 2 cm Straight Hydrophilic 190 cm
HI-TORQUE FLOPPY II™ ES 22299M 2 cm Straight Hydrophobic 190 cm
HI-TORQUE FLOPPY II™ ES 22299M-901 30 cm Straight Hydrophobic 190 cm
HI-TORQUE FLOPPY II™ ES 22359M-901 2 cm Straight Hydrophobic 300 cm

HI-TORQUE POWERTURN™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE POWERTURN™ 1044594 3 cm Straight Hydrophilic 190 cm
HI-TORQUE POWERTURN™ 1044594J 3 cm J Hydrophilic 190 cm
HI-TORQUE POWERTURN™ 1044595 3 cm Straight Hydrophilic 300 cm
HI-TORQUE POWERTURN™ 1044595J 3 cm J Hydrophilic 300 cm
HI-TORQUE POWERTURN™ FLEX 1044592 3 cm Straight Hydrophilic 190 cm
HI-TORQUE POWERTURN™ FLEX 1044592J 3 cm J Hydrophilic 190 cm
HI-TORQUE POWERTURN™ FLEX 1044593 3 cm Straight Hydrophilic 300 cm
HI-TORQUE POWERTURN™ FLEX 1044593J 3 cm J Hydrophilic 300 cm
HI-TORQUE POWERTURN™ ULTRA FLEX 1044590 3 cm Straight Hydrophilic 190 cm
HI-TORQUE POWERTURN™ ULTRA FLEX 1044590J 3 cm J Hydrophilic 190 cm
HI-TORQUE POWERTURN™ ULTRA FLEX 1044591 3 cm Straight Hydrophilic 300 cm
HI-TORQUE POWERTURN™ ULTRA FLEX 1044591J 3 cm J Hydrophilic 300 cm

HI-TORQUE TURNTRAC™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length Tip Coating
HI-TORQUE TURNTRAC™ 1020013 3 cm Straight Hydrophilic 190 cm Coated tip
HI-TORQUE TURNTRAC™ 1020013J 3 cm J Hydrophilic 190 cm Coated tip
HI-TORQUE TURNTRAC™ 1020015 3 cm Straight Hydrophilic 300 cm Coated tip
HI-TORQUE TURNTRAC™ 1020014 3 cm Straight Hydrophilic 190 cm Uncoated tip
HI-TORQUE TURNTRAC™ 1020014J 3 cm J Hydrophilic 190 cm Uncoated tip
HI-TORQUE TURNTRAC™ 1020016 3 cm Straight Hydrophilic 300 cm Uncoated tip
HI-TORQUE TURNTRAC™ FLEX 1020009 3 cm Straight Hydrophilic 190 cm Coated tip
HI-TORQUE TURNTRAC™ FLEX 1020009J 3 cm J Hydrophilic 190 cm Coated tip
HI-TORQUE TURNTRAC™ FLEX 1020011 3 cm Straight Hydrophilic 300 cm Coated tip
HI-TORQUE TURNTRAC™ FLEX 1020010 3 cm Straight Hydrophilic 190 cm Uncoated tip
HI-TORQUE TURNTRAC™ FLEX 1020010J 3 cm J Hydrophilic 190 cm Uncoated tip
HI-TORQUE TURNTRAC™ FLEX 1020012 3 cm Straight Hydrophilic 300 cm Uncoated tip

HI-TORQUE VERSATURN™ Guide Wire

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length Tip Coating
HI-TORQUE VERSATURN™ 1013317 3 cm Straight Hydrophilic 190 cm Coated tip
HI-TORQUE VERSATURN™ 1013317J 3 cm J Hydrophilic 190 cm Coated tip
HI-TORQUE VERSATURN™ 1013319 3 cm Straight Hydrophilic 190 cm Uncoated tip
HI-TORQUE VERSATURN™ 1013319J 3 cm J Hydrophilic 190 cm Uncoated tip

Coronary Specialty Guide Wires

HI-TORQUE WHISPER™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE WHISPER™ MS 1005357H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE WHISPER™ MS 1005357HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE WHISPER™ MS 1005359H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE WHISPER™ MS 1005359HJ 3 cm J Hydrophilic 300 cm
HI-TORQUE WHISPER™ ES 1011834H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE WHISPER™ ES 1011834HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE WHISPER™ ES 1011835H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE WHISPER™ ES 1011835HJ 3 cm J Hydrophilic 300 cm
HI-TORQUE WHISPER™ LS 1005351H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE WHISPER™ LS 1005351HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE WHISPER™ LS 1005353H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE WHISPER™ LS 1005353HJ 3 cm J Hydrophilic 300 cm

HI-TORQUE EXTRA S'PORT™ Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE EXTRA S'PORT™ 22225M 3 cm Straight Hydrophobic 190 cm
HI-TORQUE EXTRA S'PORT™ 22225MJ 3 cm J Hydrophobic 190 cm
HI-TORQUE EXTRA S'PORT™ 22235M 3 cm Straight Hydrophobic 300 cm
HI-TORQUE EXTRA S'PORT™ 22235MJ 3 cm J Hydrophobic 300 cm

HI-TORQUE ALL STAR™ Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE ALL STAR™ 1001740 3 cm Straight Hydrophobic 190 cm
HI-TORQUE ALL STAR™ 1001740J 3 cm J Hydrophobic 190 cm
HI-TORQUE ALL STAR™ 1001741 3 cm Straight Hydrophobic 300 cm
HI-TORQUE ALL STAR™ 1001741J 3 cm J Hydrophobic 300 cm

HI-TORQUE IRONMAN™ Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE IRONMAN™ 1001309 3 cm Straight Hydrophobic 190 cm
HI-TORQUE IRONMAN™ 1001309J 3 cm J Hydrophobic 190 cm
HI-TORQUE IRONMAN™ 1001311 3 cm Straight Hydrophobic 300 cm
HI-TORQUE IRONMAN™ 1001311J 3 cm J Hydrophobic 300 cm

HI-TORQUE CROSS-IT™ Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE CROSS-IT™ 100XT 1003309H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE CROSS-IT™ 100XT 1003309HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE CROSS-IT™ 100XT 1003310H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE CROSS-IT™ 100XT 1003310HJ 3 cm J Hydrophilic 300 cm

HI-TORQUE WIGGLE™ Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE WIGGLE™ 22299M-W2 2 cm Straight Hydrophobic 190 cm
HI-TORQUE WIGGLE™ 22299M-W30 30 cm Straight Hydrophobic 190 cm
HI-TORQUE WIGGLE™ 22359M-W2 2 cm Straight Hydrophobic 300 cm
HI-TORQUE WIGGLE™ 22399M-W30 30 cm Straight Hydrophobic 300 cm

HI-TORQUE PILOT™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE PILOT™ 50 1010480-H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PILOT™ 50 1010480-HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE PILOT™ 50 1010483-H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PILOT™ 50 1010483-HJ 3 cm J Hydrophilic 300 cm
HI-TORQUE PILOT™ 150 1010481-H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PILOT™ 150 1010481-HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE PILOT™ 150 1010484-H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PILOT™ 150 1010484-HJ 3 cm J Hydrophilic 300 cm
HI-TORQUE PILOT™ 200 1010482-H 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PILOT™ 200 1010482-HJ 3 cm J Hydrophilic 190 cm
HI-TORQUE PILOT™ 200 1010485-H 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PILOT™ 200 1010485-HJ 3 cm J Hydrophilic 300 cm

HI-TORQUE PROGRESS™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE PROGRESS™ 140T 1011840 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PROGRESS™ 140T 1011841 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PROGRESS™ 200T 1011842 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PROGRESS™ 200T 1011843 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PROGRESS™ 40 1011836 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PROGRESS™ 40 1011837 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PROGRESS™ 80 1011838 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PROGRESS™ 80 1011839 3 cm Straight Hydrophilic 300 cm
HI-TORQUE PROGRESS™ 120 1011844 3 cm Straight Hydrophilic 190 cm
HI-TORQUE PROGRESS™ 120 1011845 3 cm Straight Hydrophilic 300 cm

HI-TORQUE INFILTRAC™ Family of Guide Wires

Product Part Number Tip Radiopacity Tip Shape Distal Coatings Wire Length
HI-TORQUE INFILTRAC™ 1030001J 3 cm Micro-J Hydrophilic 190 cm
HI-TORQUE INFILTRAC™ 1030002J 3 cm Micro-J Hydrophilic 300 cm
HI-TORQUE INFILTRAC™ PLUS 1030003J 3 cm Micro-J Hydrophilic 190 cm
HI-TORQUE INFILTRAC™ PLUS 1030004J 3 cm Micro-J Hydrophilic 300 cm

Data on file at Abbott.

Important Safety Information

IMPORTANT SAFETY INFORMATION
 

rx-only-logoHI-TORQUE™ Guide Wires

 

INTENDED USE
All HI-TORQUE™ Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

INDICATIONS
Refer to the device label for any additional product-specific indications that may apply.

CONTRAINDICATIONS
HI-TORQUE™ Guide Wires Wires are not intended for use in the cerebral vasculature. Refer to the device label for any additional product-specific contraindications that may apply.

WARNINGS
This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire isplaced in a bifurcation branch, this wire may need to beretractedprior to stentdeployment because thereis additional risk that the secondary wire may become entrappedbetween the vessel wall and the stent.


PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating.

Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE™ Guide Wires for PTCA, PTA, and Stents

 

INDICATIONS FOR USE: This HI-TORQUE™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

CONTRAINDICATIONS: Not intended for use in the cerebral vasculature or with atherectomy devices.


WARNINGS:

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel and the stent.


PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp- edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE™ Guide Wires for PTCA, PTA, and Stents

 

INDICATIONS FOR USE: This HI-TORQUE™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

CONTRAINDICATIONS: Not intended for use in the cerebral vasculature or with atherectomy devices.


WARNINGS:

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.


PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp- edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE TURNTRAC™ Guide Wire

 

INDICATIONS FOR USE
This HI-TORQUE™ Guide Wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:

  • Percutaneous transluminal angioplasty (PTA)
  • Percutaneous transluminal coronary angioplasty (PTCA)

This guide wire may also be used with compatible stent devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

CONTRAINDICATIONS
Not intended for use in the cerebral vasculature.


WARNINGS
Not intended for use with atherectomy devices.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non- endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to:

  • Perforation
  • Dissection
  • Occlusion
  • Myocardial infarction
  • Embolism
  • Infection
  • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs
  • Vasoconstriction
  • Vasospasm
  • Hypotension
  • Hypertension

rx-only-logoHI-TORQUE VERSATURN™ Guide Wire

 

INDICATIONS FOR USE
This HI-TORQUE™ Guide Wire is intended to facilitate the delivery of catheter-based interventional devices during the following procedures:

  • Percutaneous transluminal angioplasty (PTA)
  • Percutaneous transluminal coronary angioplasty (PTCA)

This guide wire may also be used with compatible stent devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

CONTRAINDICATIONS
Not intended for use in the cerebral vasculature.


WARNINGS
Not intended for use with atherectomy devices.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non- endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE Guide Wires for PTCA, PTA, and Stents

 

INDICATIONS FOR USE
This HI-TORQUE™ Guide Wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatiblestent devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

CONTRAINDICATIONS
Not intended for use in the cerebral vasculature.


WARNINGS
Not intended for use with atherectomy devices.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non- endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.

PRECAUTIONS
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

HI-TORQUE™ Guide Wires with Hydrophilic Coating: Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS
Potential adverse events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE PROGRESS™ Guide Wire, HI-TORQUE PILOT™ Guide Wire for PTCA, PTA, Stents, CTO

 

INDICATIONS FOR USE: Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

CONTRAINDICATIONS: Not intended for use in the cerebral vasculature or with atherectomy devices.


WARNINGS:

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non- endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment, because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.



For the HI-TORQUE PROGRESS™ family only:
The HI- TORQUE PROGRESS™ family of guide wires has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.


PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement.

Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object.

ADVERSE EVENTS

Potential Adverse Events associated with use of this device may include the following, but not limited to: perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE WIGGLE™ Guide Wire

 

INTENDED USE
The HI-TORQUE WIGGLE™ Guide Wire is intended to facilitate the placement of the catheter by orienting the catheter tip during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and other interventional diagnostic or therapeutic procedures.

INDICATIONS
Refer to the device label for any additional product-specific indications which may apply.

CONTRAINDICATIONS
The HI-TORQUE WIGGLE™ Guide Wire is not intended for use in the cerebral vasculature.

Refer to the device label for any additional product-specific contraindications which may apply.

WARNINGS
This device is designed and intended for ONE-TIME USE ONLY. DO NOT RESTERILIZE AND / OR REUSE.

Observe all guide wire movement in the vessels. Before a guide wire is moved or torqued, the tip movement should be examined under fluoroscopy. Do not torque a guide wire without observing corresponding movement of the tip; otherwise, vessel trauma may occur.

Torquing a guide wire against resistance may cause guide wire damage and / or guide wire tip separation. Always advance or withdraw the guide wire slowly. Never push, auger, withdraw or torque a guide wire which meets resistance. Resistance may be felt and / or observed under fluoroscopy by noting any buckling of the guide wire tip. Determine the cause of resistance under fluoroscopy and take any necessary remedial action.

If the wire tip becomes entrapped within the vasculature, DO NOT TORQUE THE GUIDE WIRE.

Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform all exchanges slowly to prevent air entry and / or trauma.

When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and not against the vessel wall. Failure to do so may result in vessel trauma upon guide wire exit of the device. Use the radiopaque marker of the interventional device to confirm position.

PRECAUTIONS
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged wires. Using a damaged wire may result in vessel damage and / or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use. Test the system for any resistance prior to use. Mild to moderate resistance may be felt as the HI-TORQUE WIGGLE™ Guide Wire waves are advanced or retracted through the catheter. If severe resistance is encountered, it may be necessary to change to a catheter having a larger guide wire lumen.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

ADVERSE EVENTS
Potential Adverse Events associated with use of this device may include the following but not limited to perforation, dissection, occlusion, myocardial infarction, embolism and infection.

rx-only-logoHI-TORQUE™ INFILTRAC Guide Wire

 

INDICATIONS FOR USE
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures. The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

CONTRAINDICATIONS
Not intended for use in the cerebral vasculature.


WARNINGS
This device is not designed for use with atherectomy devices. The safety and effectiveness of the use of this HI-TORQUE™ Guide Wire with atherectomy devices is unestablished.

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse. The safety and effectiveness of this device has not been established after being reprocessed for multiple uses.

This device has a hydrophilic coating at the distal end of the device for a length of 25.6 cm, and a silicone based hydrophobic coating at the proximal end for a length of 133 cm (on 190 cm wires) and 250 cm (on 300 cm wires), and a PTFE hydrophobic coating at the proximal end for a length of 156.5 cm (on 190 cm wires) and 266.5 cm (on 300 cm wires).

Please refer to section PREPARATION FOR USE for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or results in serious adverse events. The safety and effectiveness of the device has not been established, or is unknown, in vascular regions other than those specifically indicated.

This device contains stainless steel, nickel, chromium, fluoropolymers, tin, gold, silver and platinum that may cause allergic or hypersensitivity reactions. Persons allergic to these may suffer an allergic reaction to this guide wire. Prior to use on the patient, the patient should be counselled on the materials contained in the device and a thorough history of allergies must be discussed.

Carefully observe the instructions under “Do Not” and “Do” below. Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage. If resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed. Use the most suitable guide wire for the lesion being treated.

Do Not:

  • Push, auger, withdraw, or torque a guide wire that meets resistance.
  • Torque a guide wire if the tip becomes entrapped within the vasculature.
  • Allow the guide wire tip to remain in a prolapsed condition.
  • Deploy a stent such that it will entrap the wire between the vessel wall and the stent.

Do:

  • Advance or withdraw the guide wire slowly.
  • Use the radiopaque marker of the interventional device to confirm position.
  • Examine the tip movement under fluoroscopy before manipulating, moving, or torquing the guide wire.
  • Observe the wire under fluoroscopy for tip buckling, which is a sign of resistance.
  • Maintain continuous flush while removing and reinserting the guide wire to prevent air from entering the catheter system. Perform exchanges slowly to prevent air entry and / or trauma.
  • When reintroducing the guide wire, confirm that the interventional device tip is free within the vessel lumen and that the tip is parallel to the vessel wall.
  • Use extreme caution when moving a guide wire through a non-endothelialized stent, or through stent struts, into a bifurcated vessel. Use of this technique involves additional patient risks, including the risk that the wire may become caught on the stent strut.
  • Consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.

For the HI-TORQUE INFILTRAC™ Guide Wire family only: The HI-TORQUE INFILTRAC™ Guide Wire family have distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessel, observing the information in these instructions. The higher torque performance, stiffer distal ends, and/or higher advancement force may present higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.


PRECAUTIONS

Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and/or inaccurate torque response.

Confirm the compatibility of the guide wire diameter with the interventional device before actual use.

Please refer to the indication on the label and the Instructions for Use to confirm the appropriate vasculature that this guide wire may be used in. Failure to abide by the above recommendation may result in size mismatch of blood vessel and guide wire, which can result in vessel injury, such as, but not limited to, perforation, dissection, rupture, and avulsion.

Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement. It is recommended that the user determine the source of resistance, exercise caution when removing the device and/or other components as a unit and exchange the device for a new one to complete the procedure.

Never attach the torque device to the modified portion of the proximal end of the extendable guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.

Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object. Manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer coating, which may cause coating material to remain in the vasculature. This in turn may lead to unintended adverse events requiring additional intervention.

When wet, a hydrophilic coating increases the lubricity of the guide wire surface.

Do not soak the device for longer than 4 hours when the device is not in use. Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.

The coating swells when exposed to aqueous media, but does not have any impact on the device use.

The integrity and performance of the device coating can be negatively impacted by preparation with incompatible media or solvents. Please take note of the following important recommendations:

  • Avoid wiping the device with dry gauze as this may damage the device coating.
  • Avoid excessive wiping of the coated device.
  • Avoid using alcohol, antiseptic solutions, or other solvents (e.g., use of medications and rotoflush) to pre-treat the device because this may cause unpredictable changes in the coating which could negatively affect the safety and performance of the guide wire.

Attempting to alter the shape of the devices by bending, twisting, or similar methods beyond instructed methods may compromise the coating integrity, and that damage to the coating may not always be noticeable to the naked eye.

ADVERSE EVENTS
Potential Adverse Events associated with use of this device may include the following but not limited to:

  • Allergic reaction or hypersensitivity to latex, contrast agent, anesthesia, device materials, and drug reactions to anticoagulation, or antiplatelet drugs
  • Perforation
  • Dissection
  • Bleeding
  • Occlusion
  • Myocardial infarction
  • Embolism
  • AV fistula
  • Infection
  • Vasoconstriction
  • Vasospasm
  • Hypotension
  • Hypertension
  • Death

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.