Instructions for Use - Perclose Clincher

Rx ONLY

INDICATIONS

The Clincher Knot Tying Device is indicated to tie a self-locking sliding surgical knot using USP size 3-0 suture.

CONTRAINDICATIONS

None known.

WARNINGS

Do not use The Clincher Knot Tying Device if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Clincher Knot Tying Device is intended for single use only.

KNOT TYING PROCEDURE

• Once a suture has been delivered, ensure that the needles are cut from both limbs of the suture.
• Wet The Clincher by dipping The Clincher into a sterile saline solution.
• Insert approximately five centimeters of one suture limb into snare #1.
• Pull on snare tab #1 located on the right side of The Clincher Knot Tying Device to deliver the first suture limb through the knot tying device. The suture limb will present on the right side of The Clincher Knot Tying Device. This is the non-rail suture limb.
• Insert approximately five centimeters of the other suture limb into snare #2.
• Pull on snare tab #2 at the proximal end of the knot tying device to deliver the second limb of suture through The Clincher Knot Tying Device. The suture will present at the proximal end of the device, toward the handle. This is the rail suture limb.
• Before opening The Clincher Knot Tying Device, pull through an additional five centimeters of the non-rail limb so that it is longer than the rail.
• Open The Clincher Knot Tying Device by pulling up on the tab on the right side of the device.
• Remove the knot from the device by lifting with the rail limb. Do not tighten the knot on the rail.
• Advance the sliding surgical knot to the surgical site using standard technique.
  

PRECAUTIONS

• Observe sterile technique at all times when using The Clincher Knot Tying Device.
  
• Prior to use, insure that The Clincher Knot Tying Device and packaging have not been damaged during shipment. Exercise care during device handling to reduce the possibility of accidental device breakage.
  
• The Clincher Knot Tying Device is intended for use by physicians trained in suture management (or other healthcare professionals authorized by or under the direction of such physicians).
  
• If suture limbs cannot be pulled through The Clincher Knot Tying Device, free the suture ends from the device and use another knot tying device or a manual knot tying method.
  
• In the event of suture breakage, re-tie the knot using a manual method.

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