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<h2>Indications, Safety, and Warnings</h2> <h3>Caution</h3> <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</h3> <p>The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.</p> <h3>Precautions</h3> <ul> <li>If catheter entrapment is suspected (with an embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage.</li> <li>Prior to use, carefully examine the Rebar™ Micro Catheter and its packaging to verify that it has not been damaged during shipment.</li> <li>Embolic agents must be used in accordance with manufacturer’s instructions.</li> <li>Prior to use, all accessory devices and agents should be fully prepared according to the manufacturer’s instructions.</li> <li>Always monitor infusion rates when using this micro catheter.</li> <li>The micro catheter has a lubricious hydrophilic coating on the outside of the catheter. It must be kept hydrated in order to be lubricious. This can be accomplished by attaching a Y-connector to a continuous saline drip.</li> <li>When injecting contrast for angiography, ensure that the catheter is not kinked or occluded.</li> <li>When the infusion catheter is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the catheter without observing the resultant tip response.</li> <li>Because the Rebar™ Micro Catheter may be easily advanced into narrow, selective vasculature, repeatedly verify (for example by slightly withdrawing the catheter) that the Rebar™ Micro Catheter has not been advanced so far as to interfere with its removal.</li> <li> 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.</li> </ul> <h3>Contraindictions</h3> <ul> <li>It is not intended for use in the coronary vasculature.</li> <li>The Rebar™ Micro Catheter is contraindicated when, in the medical judgment of the physician, such a procedure may compromise the patient’s condition.</li> <li>The Rebar™ Micro Catheter is contraindicated for neonatal and pediatric use.</li> </ul> <h3>Potential complications</h3> <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 such as hematoma, pain, hemorrhage, skin discoloration, nerve damage, abscess</li> <li>Adverse reactions to antiplatelet/ anticoagulation agents, contrast media, or anesthesia such as coagulopathy, organ failure, aspiration, nausea, hypotension</li> <li>Cardiac complications such as arrhythmia</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 malfunctions such as device fracture, device migration, friction, foreign body in patient</li> <li>Hematologic complications such as thrombosis, thromboembolism, embolism, gas embolism, hemolysis, intracranial hemorrhage</li> <li>Neurological deficits including stroke and death</li> <li>Systemic complications such as fever, infection, inflammation, edema, shock, toxicity, foreign body reaction, hypersensitivity, organ failure</li> <li>Therapeutic response decreased</li> <li>Vascular complications such as dissection, perforation, rupture, ischemia, vasospasm, stenosis, necrosis, granuloma, fistula, occlusion</li> </ul> <p>*Consult instructions for use for other therapy devices and medications 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> <h3>Warnings</h3> <ul> <li>Shaping Mandrel is not intended for use in the human body.</li> <li>Use only a steam source to shape the catheter tip. Do not use other heat sources.</li> <li>Prior to use, inspect the catheter tip for any damage that may have resulted from shaping. Do not use a catheter that has been damaged in any way. Damaged catheters may rupture causing vessel trauma or tip detachment during steering maneuvers.</li> <li>Infusion pressure with this device should not exceed pressure as specified in the package insert. Excess pressure may result in catheter rupture, which may result in patient injury.</li> <li>If flow through the micro catheter becomes restricted, do not attempt to clear the device by high pressure infusion. Either remove the micro catheter to determine the cause of the obstruction or replace it with a new micro catheter. Excessive pressure may cause catheter rupture, which may result in patient injury.</li> <li>Never advance or withdraw an intraluminal device against resistance until the cause of the resistance is determined by fluoroscopy. Excessive force against resistance may result in damage to the device or vessel perforation.</li> <li>This device is intended for single use only. Do not reprocess or re-sterilize. Reprocessing and resterilization increase the risks of patient infection and compromised device performance.</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>For additional Materials of Concerns information such as REACH, CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship</li> </ul> <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-2400092 (v1.0)</p>

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