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<h2>Indications, Safety, and Warnings</h2> <h3>Caution</h3> <p><b>Rist™ 071 radial access guide catheter and Rist™ 079 radial access guide catheter</b></p> <ul> <li>Federal (USA) Law restricts this device to sale, distribution, and use by or on the order of a physician.</li> <li>This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.</li> </ul> <h3>Indications for use<br /> </h3> <p><b>Rist™ 071 radial access guide catheter</b></p> <p>The Rist™ 071 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.</p> <p><b>Rist™ 079 radial access guide catheter</b></p> <p>The Rist™ 079 Radial Access Guide Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.</p> <h3>Contraindications</h3> <p><b>Rist™ 071 radial access guide catheter</b></p> <p>The Rist™ 071 Radial Access Guide Catheter is contraindicated for use with liquid embolic agents, such as n-butyl cyanoacrylate, ethylene vinyl alcohol, and dimethyl sulfoxide (DMSO) based materials.</p> <p><b>Rist™ 079 radial access guide catheter</b></p> <p>The Rist™ 079 Radial Access Guide Catheter is contraindicated for use with liquid embolic agents, such as n-butyl cyanoacrylate, ethylene vinyl alcohol, and dimethyl sulfoxide (DMSO) based materials.</p> <h3>Warnings</h3> <h4>Rist™ 071 Radial Access Guide Catheter and Rist™ 079 Radial Access Guide Catheter </h4> <ul> <li>Do not utilize variant radial artery vasculature such as the accessory radial artery.</li> <li>Do not deliver through anatomical anomalies such as radial loops.</li> <li>Vasospasm is a potential complication and may lead to entrapment of the device. Medical management of procedural vasospasm should be in line with standard medical practice.</li> <li>This device should be used only when femoral artery access is not feasible.</li> <li>When the Guide Catheter is introduced to the vascular system, it should be manipulated while under high-quailty fluoroscopic observation to minimize risk of procedural complications such as devices entering unintended anatomy or radial artery anomalies such as radial loops. Do not advance or retract the Guide Catheter if resistance is met during manipulation; determine the cause of the resistance before proceeding. </li> <li>Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in sterile barrier system integrity are evident.</li> <li>Carefully inspect the device packaging prior to use. Do not use if package appears open or damaged or if any of its components is missing. If damage is found, call your Medtronic representative.</li> <li>This device is intended for single use only. Do not reuse, reprocess or resterilize. 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.</li> <li>After radial access is achieved, torquing or moving the device against resistance may result in damage to the vessel or device separation, which may lead to potential complications, additional surgical procedures to remove device fragments, aborted or prolonged procedures.</li> <li>This device is coated with a hydrophilic coating at the distal end of the device for a length of 25 cm. Please refer to the preparation and directions sections for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this Instructions for Use may result in damage to the device coating, which may necessitate intervention or result in serious adverse events.</li> <li>This device should be used only when femoral artery access is not feasible.</li> <li>The risks and benefits of radial artery access compared to transfemoral access should be carefully weighed and considered for each patient. </li> </ul> <h3>Precautions<br /> </h3> <h4>Rist™ 071 Radial Access Guide Catheter and Rist™ 079 Radial Access Guide Catheter </h4> <ul> <li>Use the device prior to the “Use-by date" specified on the package.</li> <li>Prior to beginning radial artery access, perform a patency assessment such as an Allen or Barbeau test to ensure adequate collateral circulation of the hand. </li> <li>Radial artery measurement with ultrasound is recommended to ensure compatibility for radial access and correct device sizing selection.</li> <li>Perform a screening examination of the radial artery, such as an ultrasound assessment, to ensure that radial artery access is appropriate for the patient.</li> <li>The radial artery lumen diameter must be larger than the outer diameter of the Rist Catheter.</li> <li>If using an introducer sheath with the Rist guide Catheter, ensure the radial artery lumen diameter is larger than the outer diameter of the introducer sheath.</li> <li>Maintain a constant infusion of appropriate flush solution.</li> <li>If flow through the device becomes restricted, do not attempt to clear the lumen by infusion. Remove and replace the device.</li> <li>Examine the device to verify functionality and to ensure that its size and shape are suitable for the specific procedure for which it is to be used.</li> <li>This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.</li> <li>The selected device outer diameter should be smaller than the inner diameter of the radial artery to minimize the risk of complications.</li> <li>For other devices and fluids not supplied within this package but used in conjunction with this product, please refer to their respective Instructions for Use.</li> <li>Operators should take all necessary precautions to limit the exposure to X-ray radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors whenever possible.</li> <li>Assess the need for accessory support devices to be used throughout the intended intervention.</li> <li>Ensure there is appropriate device support along the length of the catheter throughout the intended intervention.</li> <li>Excessive manipulation of the device can increase the risk of patient complications.</li> <li>Vasospasm may occur from accessing the radial artery, thus reducing vessel lumen diameter below that which was anticipated or measured prior to the procedure.</li> <li>Vasospasm may occure while the device is within the artery. Manipulations of the device or device system increase the risk of vasospasm.</li> <li>Resistance or entrapment during a procedure may be indicative of vasospasm. Vasodilators or other appropriate therapies such as anti-coagulation, should be administered in accordance with standard medical practice and guidelines.</li> <li>Avoid wiping the device with dry gauze as this may damage the device coating.</li> <li>Avoid excessive wiping of the coated device.</li> <li>Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could affect the device safety and performance.</li> <li>Use an appropriate hemostasis valve during the procedure.</li> </ul> <h3>Potential complications</h3> <p><b>Rist™ 071 Radial Access Guide Catheter and Rist™ 079 Radial Access Guide Catheter </b></p> <p>Potential complications of the device and the endovascular procedure include or are synonymous with, but may not be limited to:</p> <ul> <li>Access site complications including sterile inflammation, granulomas, hemorrhage, hematoma, infection, nerve damage, pathological hand cold intolerance, pain and tenderness, radial artery occlusion, pseudoaneurysm, arteriovenous fistula, tissue necrosis, vasospasm, vessel dissection, compartment syndrome, amputation, vessel avulsion, hand dysfunction, radial artery perforation</li> <li>Allergic reaction including anaphylaxis from contrast media and contrast media related risks (e.g.kidney damage), hypersensitivity, foreign body reaction or adverse complication of anesthesia including aspiration</li> <li>Cardiac complications including arrhythmia, myocardial infarction</li> <li>Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts and delayed neoplasia</li> <li>Device complications including fracture, kink, friction, material left in patient</li> <li>Hematologic complications including coagulopathy, hemolysis, hemorrhage, intracranial hemorrhage</li> <li>Neurological defict/dysfuntions including stroke/cerebral infarction</li> <li>Systemic complications including hypotension, hypertension, fever, organ failure, shock, toxicity, edema (localized or generalized)</li> <li>Therapeutic response decreased</li> <li>Vascular complications including abscess, embolism (including air embolism and distal embolization to previously uninvolved territory), thromboembolism, thrombus/thrombsis, occlusion, stenosis, ischemia, fistula, perforation, rupture, vasoconstriction, extravasation</li> <li>Vision symptoms including impaired vision and vision loss</li> <li>Death </li> </ul> <p>*Consult Instructions for Use for other therapy devices and fluids for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.</p> <p>Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device or viewed at <u><a href="http://www.medtronic.com/manuals">www.medtronic.com/manuals</a></u></p> <p>US-NNP-2400089 (v2.0)</p>

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