Perclose^® ProGlide™

6F Suture-Medicated Closure (SMC) System

INDICATIONS

The Perclose ProGlide 6F SMC System is 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 8F sheaths.

The Perclose ProGlide 6F SMC Systems reduces the time to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions (refer to PRECAUTIONS, and SPECIAL PATIENT POPULATIONS).

CONTRAINDICATIONS

There are no known contraindications to the use of this device. Attention is drawn to the warnings, precautions, and special patient populations.

WARNINGS

Do not use the Perclose ProGlide 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 ProGlide SMC Device and accessories are intended for single use only.

Do not use the Perclose ProGlide SMC System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose ProGlide SMC System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site.

Do not use the Perclose ProGlide SMC System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a retroperitoneal hematoma.

Do not use the Perclose ProGlide SMC System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, since such punctures sites many result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site.

PRECAUTIONS

1. The Perclose ProGlide SMC System 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. Store in a cool, dry place.

2. Prior to use, inspect the Perclose ProGlide SMC System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function.

Exercise case during device handling to reduce the possibility of accidental device breakage.

3. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose ProGlide SMC System. Employ appropriate groin management poster procedure and post hospital discharge to prevent infection.

4. Use a single wall puncture technique. Do not puncture the posterior wall of the artery. Avoid posterior wall suture placement.

5. Do not insert the Perclose ProGlide SMC Device into the femoral artery at an angle greater than 45 degrees to the longitudinal plane of the artery.

6. There are no reaccess restrictions if previous arteriotomy repairs were achieved with Abbott Vascular SMC devices.

7. Do not advance or withdraw the Perclose ProGlide SMC Device against resistance until the cause of that resistance has been determined by fluoroscopy (see Instructions for Use for more information). Excessive force used to advance or torque the Perclose ProGlide SMC Device should be avoided, as this may lead to significant arterial damage and/or breakage of the device, which may necessitate intervention and/or surgical removal of the device and vessel repair.

8. If excessive resistance in advancing the Perclose ProGlide SMC Device is encountered, withdraw the device over a 0.038" (or smaller) guide wire and reinsert the introducer sheath or use conventional compression therapy.

9. If significant blood flow is present around the Perclose ProGlide SMC Device, do not deploy needles. Remove the Perclose ProGlide SMC Device over a 0.038" (or smaller) guide wire and insert an appropriately sized introducer sheath.

10. Remove the ProGlide sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.

11. In using this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing damage due to application of surgical instruments such as forceps or needle holders.

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