1. Advance device & lift Lever (Open Foot)

2. Maintain retraction and depress Plunger (Deploy Needles)

3. Pull back Plunger (Deploy Suture)

4. Lower Lever (Close Foot)

A. Load the blue (rail) suture limb in the Snared Knot Pusher (or in the Suture Trimmer) and advance the Suture Knot

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

C. Trim suture limbs by pulling Trimming Lever

Potential causes during Plunger deployment (Step 2)

• Rotating/rocking the device or excessive force during Plunger deployment
• Shallow (less than 45º) Plunger deployment angle

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

  45º Deployment Angle

• Ideal in healthy compliant tissue conditions
• Posterior and Anterior Foot appose evenly to compliant vessel wall

1. Position the Perclose™ device at 45º angle and keep stable with the left hand 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

• Plunger is withdrawn and no Suture is present.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

• Proper patient selection
• Deploy device at 45º angle
• Maintain gentle retraction against the vessel wall
• Stabilize device with left hand during Plunger deployment
• Ensure black Collar on Plunger contacts the device Body
• Maintain and stabilize the device at 45º angle throughout removal of Plunger/Needles and until Suture is fully retracted

Resolution

• Insert wire and exchange for another device

• Suture may look thin and elongated
• Rail or non-rail limbs can break

• 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)

• 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)

Poor Arterial Flow / No Flow

Resolution

Marker Port against vessel wall

• Do not deploy Perclose™ devices with vessel diameters <5 mm
   

Side wall stick

• Gently rotate device to move Marker Port off vessel wall
   

Low blood pressure

• Slow drip is acceptable if Perclose™ device position is confirmed
   

Clot or tissue plugging Marker Port

• Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
   

Device not in vessel lumen

• Drip can occur when Marker Port is near vessel lumen but not completely in the vessel, especially with high blood pressure or 7/8F sheaths
• Continue advancing the Perclose™ device until brisk pulsatile flow is observed

• Advance Sutures in the order of deployment

• 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

• 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