React™ Catheter INDICATIONS, SAFETY, AND WARNINGS

INDICATIONS FOR USE

The React™ 68 Catheter and React™ 71 Catheter are indicated for the introduction of interventional/diagnostic devices into the peripheral and neurovasculature.

The React™ 68 Catheter and React™ 71 Catheter are also indicated for the removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the neurovasculature.

PRECAUTIONS

• Do not use open, kinked, or damaged devices.
• Do not autoclave.
• Use the catheter in conjunction with fluoroscopic visualization.
• Inspect the catheter before use to verify that its size and condition are suitable for the specific procedure.
• Do not advance or withdraw the catheter against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torqueing the device against resistance may result in damage to the vessel or device.
• Maintain a constant infusion of appropriate flush solution.
• If flow through the catheter becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.
• Extreme care must be taken to avoid damage to the vasculature through which the catheter passes. The catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
• Torqueing the catheter may cause damage which could result in kinking and possible separation along the catheter shaft. Should the catheter become severely kinked, withdraw the catheter.
• An appropriate anticoagulation therapy should be applied per institutional guidelines.
• Operators should take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

CONTRAINDICATIONS

There are no known contraindications.

COMPATIBILITY

Refer to product label for device dimensions. Refer to labeling provided with other medical technologies to determine compatibility.

POTENTIAL COMPLICATIONS

Possible complications include, but are not limited to, the following:

• Acute occlusion
• Allergic reaction and anaphylaxis from contrast media
• Complication at puncture site
• Complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
• Embolism
• False aneurysm formation
• Infection
• Inflammation
• Intracranial hemorrhage
• Ischemia
• Neurological deficits including stroke
• Vessel spasm, thrombosis, dissection or perforation

WARNINGS

• The catheter should only be used by physicians who have received appropriate training in interventional techniques.
• Do not reuse. The device is intended for single use only. Discard the catheter after one procedure. Structural integrity and/or function may be impaired through reuse or cleaning. Catheters are extremely difficult to clean after exposure to biological materials and may cause adverse patient reactions if reused.
• The catheter has not been tested for use with automated high-pressure contrast injection equipment, do not use this equipment with the device because it may damage the device.