Perclose ProGlide Suture-Mediated Closure (U.S.)
Features & Benefits
Suture-Mediated Closure
- Delivers secure reliable vessel closure
- Designed to provide complete tissue apposition resulting in primary healing
- Provides reduced time to hemostasis, ambulation and discharge
- No re-access restrictions if previous arteriotomy repairs were achieved w/ Perclose Suture-Mediated Closure-device
Polypropylene Monofilament Suture
- Retains knotted tensile strength
- Easier knot delivery
- Designed to minimize inflammatory response
Auto-Tie
- Automated knot tying with pre-tied, heat set knot
- Reduced procedure time
QuickCut Mechanism
- Reduced cost of extra sharps
- Single operator procedure
Simple to Learn
- Device Numbered with Deployment Sequence
- Easy deployment
- Deployment steps 155 KB
Ergonomic Design
- Allows for single operator procedure
- Short sheath compatible with long and short wires
- Hydrophilic coated straight tip sheath facilitates insertion
Ordering Information
Designed for use in 5 to 8 F access sites following diagnostic or interventional catheterization procedures
Product Code/ Catalog # 12673
Sold 10 systems per box
Included in Perclose ProGlide System Package: 1 Perclose ProGlide,1 Suture Trimmer, 1 Knot Pusher
Indications and Important Safety Information
Perclose
ProGlide Suture-Mediated Closure System
INDICATIONS FOR USE
The Perclose ProGlide 6F SMC System 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 8F sheaths.
The Perclose ProGlide 6F 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, 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.
SPECIAL PATIENT POPULATIONS
The safety and effectiveness of the Perclose ProGlide SMC Devices have not been established in the following patient populations:
• Patients with introducer sheaths < 5F or > 8F during the catheterization procedure.
• Patients with access sites above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks.
• Patients with access sites in the profunda femoris or superficial femoral arteries.
• Patients with access sites distal to the bifurcation of the superficial femoral and profunda femoris arteries.
• Patients having a hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal.
• Patients with femoral artery calcium which is fluoroscopically visible at access site.
• Patients with small femoral arteries (< 5 mm in diameter).
• Patients with severe claudication, iliac or a femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of access site.
• Patients with access sites in vascular grafts.
• Patients with poor intra-aortic balloon pump at access site.
• Patients with ipsilateral femoral venous sheath during the catheterization procedure.
• Patients with which there is difficulty inserting the introducer sheath or greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure.
• Patients with intra-procedural bleeding around access site.
• Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure.
• 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 (Body Mass Index > 35 kg/m2).
• Patients with active systemic or cutaneous infection or inflammation.
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
For a complete list of potential Adverse Effects please refer to the complete Instructions for Use.
The following adverse effects have been reported and may occur:
• Surgical repair • U/S guided
compression • Transfusion •Infection requiring IV Abx • Hematoma ≥ 6 cm •
AV-fistula • Pseudoaneurysm • Vascular narrowing
• Infection requiring IM/PO Abx • Retroperitoneal bleed
AP2929608 Rev. A
