Instructions for Use (Brief Summary) - Perclose Snared Knot Pusher
Rx ONLY
DESCRIPTION
The Perclose Snared Knot Pusher is designed to position the tied suture knot to the arteriotomy.
INDICATIONS
The Snared Knot Pusher is indicated for use with the Perclose Closer S, Perclose A-T and the Perclose ProGlide Suture Closure Devices. Please refer to the Perclose Closer S, Perclose A-T or the Perclose ProGlide IFU for complete device information.
CONTRAINDICATIONS
None known.
WARNINGS
Do not use the Perclose A-T Device or accessories 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 Perclose A-T SMC Device and accessories are intended for single use only.
PRECAUTIONS
Observe sterile technique at all times when using The Perclose Snared Knot
Pusher.
Prior to use, insure that The Perclose Snared Knot Pusher and packaging have
not been damaged during shipment. Exercise care during device handling to
reduce the possibility of accidental device breakage.
The Perclose Snared Knot Pusher is intended for use by physicians trained in
suture management (or other healthcare professionals authorized by or under the
direction of such physicians).
SNARED KNOT PUSHER PROCEDURE
Place approximately 2cm of the rail suture into the snare at the distal end
of Snared Knot Pusher.
Load the suture into the Snared Knot Pusher by pulling the snare through the
tip of the Snared Knot Pusher.
Once loaded, The Snared Knot Pusher should slide easily on the suture.
Wet the suture with saline.
Securely wrap the rail suture around your left forefinger.
Gently pull on the rail suture, keeping the suture coaxial to the tissue
tract.
Completely remove the device or the arterial sheath (if the device was deployed
at the beginning of the catheterization procedure) from the artery. Do not
tighten the suture around the sheath.
With the rail suture securely wrapped around your left forefinger, place the
Snared Knot Pusher under your left thumb to assume a single-handed position and
to complete knot advancement.
With the Snared Knot Pusher in place, tighten the knot by gently pulling on the
non-rail suture.
Remove the Snared Knot Pusher from the tissue tract and test for hemostasis by
having the patient cough or bend his/her leg.
Please refer to the Perclose Closer S, Perclose A-T or the Perclose ProGlide
IFU for complete device information.
PRODUCT INFORMATION DISCLOSURE
Abbott Vascular Devices has exercised reasonable care in the manufacture of this device. Abbott Vascular Devices excludes all warranties, whether expressed or implied, by operation of law or otherwise, including but not limited to, any implied warranties of merchantability or fitness, since handling and storage of this device, as well as factors relating to the patient, diagnosis, treatment, surgical procedures, and other matters beyond Abbott Vascular Devices’ control, directly affect this device and the results obtained from its use. Abbott Vascular Devices shall not be liable for any incidental or consequential loss, damage, or expense, directly or indirectly arising from the use of this device. Abbott Vascular Devices neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device.
HOW SUPPLIED
The Perclose Snared Knot Pusher is provided sterile and non-pyrogenic in unopened, undamaged packages. Products are sterilized with ethylene oxide and intended for single use only. Do not resterilize. Device and primary packaging do not contain latex. Store in a cool, dry place.
The Perclose Snared Knot Pusher List/REF 12352
LT2922560
