• Interlaced Nitinol Loops designed to resist prolapse and improve capture by allowing the snare to move as a single-unit through the vessel.
• Embedded Radiopaque Marker Band identifies the snare delivery catheter’s precise location under imaging.
• Improved Vessel Navigation facilitated by 15 degree curved tip on 6F and 7F snare delivery catheters.
• High Performance Snare Delivery Catheter designed for strength and to minimize the potential for kinking and buckling.
• Enhanced Visualization provided by platinum strands incorporated into the loops
• 
• Available in seven configurations with loop diameter sizes ranging from 2 mm to 45 mm.

WARNINGS:

1. This device is not intended for the removal of foreign objects entrapped by tissue growth.

2. This device should not be used for fibrin sheath stripping in the presence of septal defects of Persistent Foramen Ovale.

3. This device is not intended for removal of implanted pacing leads.

4. Pull forces applied to catheters during fibrin sheath stripping may damage, stretch, or break indwelling catheters 6 French or smaller in diameter. Do not use excessive pull force when attempting fibrin sheath stripping of catheters 6 French or smaller in diameter.

5. Do not use excessive force when manipulating the catheter through an introducer. Excessive force may damage the catheter.

6. This device has been sterilized utilizing Ethylene Oxide and is considered sterile if the package is not opened or damaged. It is intended for Single Patient Use Only. Do not attempt to clean or re-sterilize the device. After use this device may be a potential biohazard. Handle in a manner that will prevent accidental contamination. Do not use a device that has been damaged or if the package is open or damaged.

7. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

8. Nitinol is a nickel titanium alloy. Possible reaction may occur for those patients who exhibit sensitivity to nickel.

POTENTIAL COMPLICATIONS:

1. Potential complications associated with foreign body retrieval devices in arterial vasculature include, but are not limited to:

• Embolization

• Stroke

• Myocardial infarction (depending upon placement)

2. Potential complications associated with snare retrieval devices in venous vasculature include, but are not limited to:

• Pulmonary embolism

3. Other potential complications associated with foreign body retrieval devices include, but are not limited to:

• Vessel perforation

• Device entrapment Catheter damage can occur when attempting fibrin sheath stripping on small French size diameter catheters