React 68 CatheterINDICATIONS, SAFETY, AND WARNINGS
INDICATIONS FOR USE
The React™ 68 Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
CAUTION: Federal (USA) law restricts this device to sale distribution and use by or on order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
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.
There are no known contraindications.
Possible complications include, but are not limited to, the following:
allergic reaction and anaphylaxis from contrast media
false aneurysm formation
complication at puncture site
complication of radiation exposure ( e.g. alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
neurological deficits including stroke
vessel spasm, thrombosis, dissection or perforation
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.