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Perclose ProGlide™

Suture-Mediated Closure System

Perclose ProGlide
Deployment

Deployment & Suture Management

4 Key Steps to Suture Deployment

Refer to Instructions for Use (IFU) for additional information.

Suture Deployment Open Foot

1. Advance device & lift Lever (Open Foot)

Maintain retraction and depress plunger

2. Maintain retraction and depress Plunger (Deploy Needles)

Pull back plunger (deploy suture)

3. Pull back Plunger (Deploy Suture)

Lower lever (close foot)

4. Lower Lever (Close Foot)

Suture Management

Refer to Instructions for Use (IFU) for additional information.

Suture Management Step A

A. Capture blue (rail) suture limb in Suture Gate and advance Suture Knot

Suture Management Step B

B. Lock Suture Knot by pulling white (non-rail) suture limb

Suture Management Step C

C. Trim suture limbs by pulling Trimming Lever

Single and Multiple Device Deployment

Refer to Instructions for Use (IFU) for additional information.

View the animation library for full deployment steps for single and multiple devices.

Single Device Deployment

Perclose ProGlide single device deployment

Multiple Device Deployment

Multiple device deployment

Tips and Techniques

Refer to Instructions for Use for additional information.

 

Poor Flow

Arterial Poor Flow

Arterial poor flow
Causes
  • Marker Port is against the vessel wall
  • Side wall stick
  • Low blood pressure
  • Clot or tissue plugging Marker Port
  • Device not in vessel lumen

Venous Poor Flow

Venous poor flow
Resolution For Poor Flow
  • If vessel is not ≥ 5 mm, do not deploy
  • Gently rotate device
  • Slow drip is acceptable
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
  • Continue inserting device until brisk pulsatile flow occurs in the artery and slow drip occurs in the vein

Suture Break

Causes/Prevention

Suture break causes/prevention
  • Suture may look thin and elongated
  • Rail or non-rail limbs can break
Suture break step 1
  • Load Suture at mid-point of Suture Trimmer (Do not load at tip)
  • Keep Thumb Knob retracted until Suture limbs drop into Suture Gate (Do not close Suture Gate on the Suture)
Suture break step 2
  • Keep Thumb Knob toward ceiling (Do not rotate Suture Trimmer)
  • Keep suture limbs coaxial to Suture Trimmer and tissue tract at all times
  • Do not pull laterally or medially on Suture
  • Apply slow, consistent, increasing tension (Avoid quick, jerky movements)

Resolution

Suture break resolution
  • If the device is still in place
    Insert wire and exchange for another device
  • If closing over the wire
    Insert and deploy another device
  • If device is already removed and no wire access, assess hemostasis
    Manual compression may be necessary, depending on when and where the Suture broke

Cuff Miss

No suture or link present
No suture or link present
Cuff and link present, no suture
Cuff and link present, no suture
  • Plunger is withdrawn and no Suture is present. The link may or may not be attached to Anterior Needle
  • Tip(s) of Needle(s) did not lock with Cuff(s)

Prevention

Cuff miss 1
  • Proper patient selection
  • Deploy device at 45° stabilize device with left hand during Plunger deployment
Cuff miss 2
  • Ensure black Collar on Plunger contacts purple Body
Cuff miss 3
  • Maintain and stabilize the device at 45° throughout removal of Plunger/Needles and until Suture is fully retracted

Resolution

  • Insert wire and exchange for another device

Foot Break

Causes/Observations

Potential causes during Plunger deployment (Step 2)
  • Rotating/rocking the device or excessive force during Plunger deployment
  • Shallow (less than 45º) Plunger deployment angle
Observations after plunger removal
Potential observations
Potential observations after Plunger removal (Step 3) and/or device removal
  • No Suture or link present
  • Just a link and no Suture present
  • Missing part of Foot when the device is removed

Prevention

Foot Break prevention
  1. Stable and position the device at 45º angle during Plunger deployment
    • The deployment angle may vary slightly depending on anatomy
  2. Maintain even and gentle tension over the Anterior and Posterior Foot against the vessel wall
    • The key is to raise the device until pressure is evenly distributed across the Anterior and Posterior Foot
  3. Press down on the Plunger with a gentle, increasing pressure to advance the Needles
    • The Needles are more susceptible to deflecting off calcification with higher Plunger force and higher Needle speed
Deployment Angle During plunger deployment (Step 2)
shallow deployment angle

  Shallow Deployment Angle

  • Sub-optimal in any tissue conditions
  • Potential gap between Posterior Foot and vessel wall increases chance for foot break and cuff miss
45 degree deployment angle

45º Deployment Angle

  • Ideal in healthy compliant tissue conditions
  • Posterior and Anterior Foot appose evenly to compliant vessel wall
deployment angle
  • Important in diseased non-compliant tissue conditions
  • Maintain even and gentle tension to position Posterior Foot close to non-compliant vessel wall
exercise
Exercise:

Use an actual device, observe the different foot deployment angles

Note: Best if protractor is viewed on a small screen or print out

Foot Break Prevention
foot break prevention 1
  • Avoid challenging anatomical conditions such as heavily calcified arteries, scarred groins, etc
  • These conditions may make the Needles more susceptible to deflecting
Foot break prevention 2

Before attempting to remove the device:

  • Relax the device before pushing the Lever down
  • Push the Lever down to return Foot to the closed position
Foot break prevention 3

Lack of Hemostasis

Lack of hemostasis may be a result of incorrect order of knot advancement or tangled sutures.

Incorrect Order of Knot Advancement
advance sutures in order of deployment
  • Advance Sutures in the order of deployment
first suture deployed is on the bottom
  • First Suture deployed is on the "bottom" or closest to the vessel. If Second Suture is tightened out of order, it may result in tangled Sutures and/or the inability to tighten the First Suture successfully
knot advancement of all sutures
  • After initial knot advancement of all Sutures, continue to tighten and lock each knot in the order deployed
  • Tightening and locking the Second Suture before the First Suture is completely secure can result in an incomplete or "partial" close
Tangled Sutures
tangled sutures 1
  • After Suture Deployment, a clamp is immediately placed on the Suture limbs. A gentle retraction is placed on the clamp until the Suture is taut. This removes all Suture slack from the tissue tract
tangled sutures 2
  • If Suture slack is not removed, the Sutures can become tangled or pushed into the vessel during insertion of procedural sheaths and device exchanges
tangles sutures 3

References

  1. Perclose ProGlide - Instructions for Use (IFU). Refer to IFU for additional information.

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