CARDIOVASCULAR
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Multiple Device Deployment

Refer to Instructions for Use for additional information.

Pre-Close Technique

  • Pre-close technique means the Perclose ProGlide™ suture is placed around the arteriotomy at the beginning of the procedure and knot advancement is placed on hold until the procedure is complete
  • The pre-close technique for sheath sizes greater than 8F, at least two devices and the pre-close technique are required
Flush Marker Lumen

Pre-Deployment

  • Flush Marker Lumen
Flush Marker Lumen
  • Insert the first of two devices over the guide wire
  • Remove guide wire when Guide Wire Exit Port is at skin level
  • Advance device until pulsatile flow is observed from Marker Lumen. In the vein, blood may only fill the Marker Lumen
  • Rotate the device 30° toward the patient's right side
Flush Marker Lumen

Suture Deployment

1a. Lift Lever to open Foot. Do NOT open Foot before rotating device 30°

1b. Retract device against anterior wall of vessel until marking has stopped

Multi Suture Deploy

2. Stabilize device at 45º while maintaining gentle retraction against the vessel wall. Depress the plunger to deploy the needles.

Multi Suture Deploy

3. Remove Plunger using the thumb as a fulcrum. Pull suture taught. Cut suture with QuickCut or scissors

Multi Suture Deploy

4. Relax device and return Lever down to its original position

Multi Suture Deploy

Suture Management

  • Retract device until Guide Wire Exit Port is at skin level
  • Remove the sutures and hold sutures tightly together
    • Blue limb = Rail
    • White limb = Non-Rail
Suture Management
  • Place a hemostat or clamp to hold the two sutures together at the distal end of the Non-Rail (white)
  • Pull on clamp until the suture is taut. Place clamped suture on patient's right side under sterile towel
Suture Management
  • Re-insert guide wire and remove device
Suture Management

Second Device Deployment

  • Repeat Pre-Deployment steps for each device
  • Second Device
    • Insert the device and rotate 30° toward the patient's left side and repeat deployment steps
    • Repeat suture management steps and place clamped suture on patient's left side under sterile towel
    • Knot advancement will be on hold until the end of procedure
Second Deployment
  • Third device (optional as needed)
    • Third device should not be rotated. Device will deploy in a straight position
Second Deployment

 

Second Deployment

End-of-Procedure Suture Management

  • At the end of the procedure, advance a guide wire into the vessel
  • Remove clamp from first suture placed at patient's right side

    NOTE: Hold manual compression during sheath system removal and initial suture advancement

  • Wrap Rail (blue) around left forefinger and hold coaxial to tissue tract
  • Remove sheath and pull Rail (blue) simultaneously and slowly to advance suture knot
EOP Suture Management
  • Re-clamp and return the suture to the right side of the patient to identify the first sutures deployed
  • Repeat steps above for suture set 2 and place on left side of patient. Repeat for suture set 3 if a third device was deployed
  • Do not lock or excessively tighten the knot while the guide wire is in the vessel
EOP Suture Management
  • Use Snared Knot Pusher (SKP) to complete knot advancement and to lock the knot
  • The suture knots must be advanced in the order they were placed
  • Load Snared Knot Pusher (SKP) on to Rail (blue) suture of the first suture set placed on patient's right side
EOP Suture Management
  • Advance Shared Knot Pusher (SKP) coaxial down to the vessel
  • Pull on the Non-Rail (white) suture to lock the knot
  • Repeat steps for sutures placed on patient's left side
  • Remove guide wire once bleeding is controlled
  • Load Snared Knot Pusher (SKP) on to Rail (blue) suture patient's right side and lock knot by pulling on the Non-Rail (white) suture
  • Repeat for sutures placed on the patient's left side
EOP Suture Management

Assess Hemostasis

  • Assess hemostasis after all knots are advanced and locked
  • If adequate hemostasis is not observed, advance each knot again starting with the first suture deployed followed by the second suture deployed
  • Trim all sutures once adequate hemostasis is observed
Assess Hemostasis
Important Safety Information

MAT-2002632 v2.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

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