Accuracy



• Gold-plated tungsten loop is highly visible under fluoroscopy to provide true orientation.
• Radiopaque marker band on the snare delivery catheter identifies its precise location.
• 90-degree angle loop for a coaxial approach to foreign body capture.
• Nitinol core wire combines shape memory and superelasticity for support during vessel navigation.

Reliability

• Nitinol and gold-plated tungsten loop retains its circular shape to support the capture of foreign bodies.
• Snare delivery catheter is constructed of a high performance copolymer material which offers strength during foreign body retrieval to minimize the potential for kinking and buckling.
• The strain-relief hub of the snare delivery catheter provides extra flexibility during deployment and use.
• Insertion tool with unique, peel-away design provides quick and efficient snare loading.
• Easy-to-grip torque device supports snare torqueability.

Options

• Available in fifteen kit configurations with ten loop diameter sizes ranging from 2 mm to 35 mm.

CONTRAINDICATIONS:

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.

WARNINGS:

1. 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.

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

3. This device has been sterilized utilizing ethylene oxide and is considered sterile if the package is not opened or damaged. Do not use a device that has been damaged or if the package is open or damaged.

4. For single patient use only. Do not reuse, reprocess or sterilize. 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.

5. After use this device may be a potential biohazard. Handle in a manner that will prevent accidental contamination.

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

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

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.