Hi-Torque Versacore™

Indications

The Hi-Torque Versacore™ Guide Wire is indicated for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.
 

Contraindications

The Hi-Torque Versacore™ Guide Wire is not intended for use in the coronary or cerebral vasculature.
 

Warnings

This device is not designed for use with atherectomy devices.

The lifetime of the device is the labeled shelf life. This device is designed and intended for one time use only. Do not resterilize and / or reuse. The safety and effectiveness of this device have not been established after being reprocessed for multiple uses.

Use extreme caution and careful judgement in patients for whom anticoagulation is not indicated.

If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.

Persons with known history of allergies to any of the components of this device listed below may suffer an allergic reaction to this guide wire: stainless steel, polytetrafluoroethylene (PTFE) coating, gold-silver-copper-zinc alloy, silver-copper-zinc-nickel alloy, high density polyethylene, low density polyethylene, silicone coating, and cyanoacrylate ester. Prior to its use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed.

This device has a hydrophobic coating at the proximal end and a hydrophobic coating on the distal end of the device that enhances the penetration capacity and provides good torque control for lengths as specified in the table below:

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 result in serious adverse events.

Limitations

PTA should only be performed at centers where emergency peripheral artery bypass surgery is available.
 

Precautions

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 Abbott-compatible Guide Wire Extension.

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.

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.

Avoid abrasion of the coating. Do not withdraw or manipulate the coated guide 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.

After use, this product may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

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 devices.
• Avoid using alcohol, antiseptic solutions, or other solvents 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.

One or more components of this device may contain the following substance defined as

CMR 1B in a concentration above 0.1% weight by weight: Cobalt; Chemical Abstracts Service (CAS) No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports that medical devices manufactured from stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.

The safety and effectiveness of this Hi-Torque Versacore™ Guide Wire have not been established in the pediatric population.
 

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
• Vascular access complications which may require transfusion or vessel repair, including:
  • Bleeding (ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage)
  • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, and laceration
  • Embolism (air, tissue, plaque, thrombotic material, or device)
• Target artery complications which may require additional intervention, including:
  • Total occlusion or abrupt closure
  • Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture
  • Embolism (air, tissue, plaque, thrombotic material, or device)
  • Artery or stent thrombosis
  • Stenosis or restenosis
  • Vessel spasm
  • Claudication
• Venous thromboembolism (including pulmonary embolism)
• Hypotension / hypertension
• Peripheral nerve injury, neuropathy
• Other ischemic conditions / infarct
  • Tissue / organ ischemia
  • Tissue necrosis
  • Ulcer
  • Acute limb ischemia
• Infection – local and systemic (including post-procedural)
  • Abscess
  • Sepsis / infection including bacteremia / cellulitis / septicemia
  • Contrast-induced renal insufficiency or renal failure
  • Death