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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>The Medtronic guide catheter is designed to provide a pathway through which therapeutic devices are introduced. The guide catheter is intended to be used in the coronary or peripheral vascular system.<br /> </p> <h3>Warnings<br /> </h3> <ul> <li>This device was designed for single use only. Do not reuse, reprocess or resterilize this device. Reuse, reprocessing or resterilization may compromise the structural integrity of the device or create a risk of contamination, which could result in patient injury, illness, or death.</li> <li>Visually inspect all sterile-barrier packaging before use. If the integrity of the sterilization barrier has been compromised or the device is damaged, do not use the product. Contact your Medtronic representative for return information.</li> <li>Take care to avoid damaging the vessel walls through which this catheter passes.</li> <li>When using the catheter in smaller vessels, ensure that it does not completely block blood flow.</li> <li>Do not use after the use-by date.</li> <li>Use aseptic technique during the entire procedure.</li> <li>Failure to abide by these instructions for use may result in damage to the device coating, where applicable, which may necessitate intervention or result in serious adverse events.</li> <li>When there is limited clearance between devices and the guide catheter lumen, devices must be advanced and withdrawn slowly with the valve open to reduce the risk of embolism.</li> </ul> <h3>Precautions<br /> </h3> <ul> <li>The large internal diameter of the catheter permits the injection of substances with little force being required on the syringe. Inject substances slowly whenever attempting to visualize the vessels under angiography.</li> <li>The catheter is supplied sterile and nonpyrogenic.</li> <li>Store the device at room temperature in a dry place. Keep the device away from sunlight or UV light.</li> <li>Do not force passage if resistance is encountered during the insertion of the interventional device through the lumen of the guide catheter. Determine the cause of resistance before proceeding. If the cause of resistance cannot be determined, it is recommended that all devices potentially contributing to the resistance be carefully removed and replaced, as necessary. Consider withdrawing all devices simultaneously.</li> <li>Use caution when handling the guide catheter to reduce the possibility of bending or kinking. If the guide catheter becomes kinked, do not torque the device. Instead, carefully withdraw the catheter, any devices within it, and, if needed, the introducer sheath.</li> <li>Dispose of the device in accordance with applicable laws, regulations, and hospital procedures, including those regarding biohazards, microbial hazards, and infectious substances.</li> </ul> <h3>Adverse effects<br /> </h3> <p>Adverse events that may occur or require intervention include, but are not limited to, the following conditions: hemorrhage, hematoma, infection, embolism, vessel, heart, or heart wall damage, perforation, or dissection, vessel spasm, thrombosis, myocardial infarction, stroke, death, vascular occlusion, or allergic reaction.<br /> </p> <p>If a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.</p> <p>UC202311555 EN</p>

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