Instructions for Use (Brief Summary) - Perclose Suture Trimmer

Rx ONLY

PERCLOSE A·T 6 FRENCH SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Description

The Perclose® A-T (auto tie) Suture Mediated Closure (SMC) Devices are designed to deliver polyester suture to close femoral artery puncture sites following diagnostic or interventional procedures. The Perclose A-T device has one suture and two needles.

This SMC Device is composed of a sheath and a guide that houses the needles and the foot and precisely controls the placement of these needles around the puncture site. A marker lumen is contained within the guide, with the intraluminal port of the lumen positioned at the distal end of the needle guide. Proximally, the marker lumen exits from the handle of the device. The marker lumen allows a pathway for back-bleeding from the femoral artery to ensure proper device positioning. The Perclose A-T tracks over a standard .038” (or smaller) guidewire.

A Perclose knot pusher (Suture Trimmer and/or Snared Knot Pusher) is included as an accessory and is designed to position the tied suture knot to the arteriotomy.

The Perclose A-T 6 Fr. SMC System is designed for use in 5 to 8 Fr. access sites.

INDICATIONS FOR USE

The Perclose A-T 6 Fr. SMC Systems are indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 8 Fr. sheaths. The Perclose A-T 6 Fr. SMC Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions (refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS).

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
The Perclose A-T SMC System should only be used by physicians or other healthcare professionals authorized by or under the direction of such physicians after they have been trained in the use of the Perclose A-T SMC System, e.g. participation in the Perclose A-T SMC System training program or equivalent.

The Perclose A-T SMC Device should be used only by operators trained in its use, e.g., via participation in a Closer SMC Device training program or equivalent.

Observe sterile technique at all times when using the Perclose A-T SMC System. Employ appropriate groin management post procedure and post hospital discharge to prevent infection.

Use a single wall puncture technique. Do not puncture the posterior wall of the artery.

Do not advance or withdraw the Perclose A-T SMC Device against resistance until the cause of that resistance has been determined by fluoroscopy. If excessive resistance in advancing the Perclose A-T SMC Device is encountered, withdraw the device over a 0.038” (or smaller) guidewire and reinsert the introducer sheath or use conventional compression therapy. Excessive force used to advance or torque the Perclose A-T SMC Device should be avoided, as this may lead to significant arterial damage.

If significant blood flow is returned through the barrel of the Perclose A-T SMC Device, do not deploy needles. Remove the Perclose A-T SMC Device over a guidewire and insert an appropriately sized introducer sheath.

Use conventional compression methods in the event bleeding from the femoral access site persists after the use of Perclose A-T SMC Device.

SPECIAL PATIENT POPULATIONS
The safety and effectiveness of the Perclose A-T SMC Devices have not been established in the following patient populations:

Patients with puncture sites in the profunda femoris or superficial femoral arteries.
Patients having a hematoma, pseudoaneurysm or arterio-venous fistula present prior to sheath removal.
Patients with common femoral artery calcium which is fluoroscopically visible.
Patients with small femoral arteries (<5 mm in diameter).
Patients with a femoral artery stenosis greater than 50%.
Patients with puncture sites in vascular grafts.
Patients with antegrade punctures.
Patients who are pregnant or lactating.
Patients with bleeding diathesis or coagulopathy.
Patients younger than 18 years of age.
Patients with ipsilateral arterial access sites punctured and compressed within 48 hours of closure.
Patients who are morbidly obese where less than one third of the access needle is above the skin line.
Before considering early discharge, assess the patient for the following clinical conditions:

conscious sedation
anticoagulation, thrombolytic, or antiplatelet therapy
unstable cardiac status
hematoma at the closure site
hypotension
pain while walking
bleeding at the closure site
any comorbid condition requiring observation.
The presence of any of the above factors has generally led to the deferral of early discharge recommendations.

ADVERSE EFFECTS
The following adverse effects have been reported and may occur:

surgical repair
U/S guided compression
transfusion
infection requiring IV Abx
hemotoma > 6 cm
AV-fistula
pseudoaneurysm
vascular narrowing
infection requiring IMPO Abx
retroperitoneal bleed

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