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<h2>Indications, Safety, and Warnings</h2> <h3><span style="font-weight: normal;">Indications</span></h3> <p>DxTerity™ diagnostic catheters are indicated for cardiac and vascular procedures. The diagnotic catheters are designed to deliver radiopaque media, guidewires, and theraputic agents to selected sites in the cardiovascular system. The different configurations of the diagnostic catheter are designed to be used in arteries, from access sites such as the radial, brachial, and femoral arteries.</p> <h3><span style="font-weight: normal;">Contraindications</span></h3> <p>None specific to this device.</p> <h3><span style="font-weight: normal;">General warnings and precautions</span></h3> <ul> <li>Read all instructions carefully. Failure to follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient. </li> <li><b>Warning:</b> This device was designed for single-patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device, which could result in patient injury, illness, or death.</li> <li>Visually inspect all sterile-barrier packaging before use. If the device is damaged or the integrity of the sterilization barrier has been compromised, do not use the product. Contact your Medtronic representative for return information.</li> <li>Do not use after the Use-by date.</li> <li>Use aseptic technique during the entire procedure.</li> </ul> <p> </p> <ul> <li><b>Warning:</b> Administer appropriate anticoagulation therapy to reduce potential thrombosis. If the patient is not appropriately anticoagulated, thrombus formation may occur. Testing without anticoagulation shows variable amounts of thrombus formation on the device surface.</li> <li>After use, this product may be a biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.</li> <li>Only physicians trained in intravascular angiographic procedures should use or supervise use of the diagnostic catheter.</li> <li>Select a diagnostic catheter with an optimal tip shape and optimal size, taking into account the access site, the target site, and the patient’s anatomy. Carefully inspect the diagnostic catheter before use to verify that the size, shape, and condition of the catheter are suitable for the intended procedures.</li> <li>Store the device at room temperature in a dry place. Keep away from sunlight or UV light.</li> <li>The diagnostic catheter is supplied sterile and nonpyrogenic.</li> <li>Do not heat or bend the diagnostic catheter before use.</li> </ul> <h3><span style="font-weight: normal;">Adverse events</span></h3> <p>Adverse events that may occur or require intervention include, but are not limited to, the following conditions:</p> <ul> <li>Thrombus formation</li> <li>Embolization</li> <li>Infection</li> <li>Arterial, venous, or heart wall damage or perforation</li> <li>Hematoma at puncture site</li> <li>Cardiac arrhythmia</li> <li>Myocardial infarction</li> <li>Vascular occlusion</li> <li>Death</li> <li>Access pain site</li> <li>Allergic and neurological reactions</li> <li>Stroke and transient ischemic attack</li> <li>Vasospasm</li> <li>False aneurysm</li> <li>Arteriovenous fistula</li> </ul> <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><b>Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. See package inserts for the full product information.</b></p> <p>UC202311547 EN</p>

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