Loop Design

• Multiple, independent, short profile loops with tips on each loop for complete vessel coverage
• Platinum strands to provide excellent fluoroscopic visualization

Construction

• Shaft and loops made with nitinol wire for 1:1 torque control and kink resistance
• Three overlapping, independent loops allow for self-sizing to adjust to changing vessel diameter

Delivery Catheter

• 15° angled tip (6 Fr & 7 Fr sizes only) assists with navigation through tortuous anatomy
• Radiopaque band for increased visibility under fluoroscopy

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 was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize this device.

7. Inspect the package integrity before use.

8. Do not use if package is open or damaged or if the expiry date has been exceeded.

9. Do not continue to use if any of the component are damaged during the procedure.

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

11. Possible reaction may occur for those patients who exibit sensitivity to platinum.

Precautions:

1. This device is intended for use by a qualified physician.

2. Care should be observed when using this device for removal of a large fibrin sheath in order to minimize risk of pulmonary embolism.

3. Bleeding may occur through the delivery catheter hub during some procedures. A hemostasis valve (not included) can be attached to the delivery catheter to reduce the bleeding as needed or per physician’s judgment.

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 foreign body 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 (See WARNINGS). Incidence of pulmonary embolism after fibrin sheath stripping may occur