C304-HIS

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<h2>Indications, Safety, and Warnings</h2> <h3>Indications (or Intended Use)</h3> <p>The device is indicated to provide a pathway through which diagnostic and therapeutic transvenous devices are introduced within the chambers and coronary vasculature of the heart and for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus.</p> <h3>Contraindications</h3> <p>Use of the device is contraindicated for patients with obstructed or inadequate vasculature and for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve.</p> <h3>Warnings and Precautions</h3> <ul> <li>The device is for single use only and is not intended to be resterilized.</li> <li>Use the deflectable catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of the deflectable catheter with any device not manufactured by Medtronic. For the C304 Catheters, no test data is available to demonstrate compatibility of the transvenous devices with an outer diameter larger than 1.5mm (4.6Fr), with the exception of the 1.85mm (5.6Fr) dilator included with the device package. Consequences of using the deflectable catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.</li> <li>Thrombogenicity evaluations were conducted using a heparinized model. If your patient cannot be adequately anticoagulated, it is unknown whether thrombus formation may occur with this product.</li> <li>Handle the deflectable catheter with care at all times. Do not kink, stretch, or severely bend the deflectable catheter. Do not use surgical instruments to grasp the deflectable catheter. Avoid contact with liquids other than isopropyl alcohol, blood, saline, or contrast solution.</li> <li>Use the valve to impede the back flow of venous blood during the implant procedure. Ensure that the flush port stopcock is closed before attaching the valve to the deflectable catheter hub.</li> <li>Keep external defibrillation and backup pacing readily available during implant. Use of the device, transvenous devices, or both may cause heart block.</li> </ul> <h3>Potential Adverse Events or Potential Complications</h3> <p>Potential adverse events related to the use of the deflectable catheter may include, but are not limited to, the following events: air embolism, allergic reaction to contrast media, arteriovenous fistula formation, bleeding at the insertion site, brachial plexus injury, cardiac tamponade, dislodgement, dissection, endocarditis, heart block, hematoma formation, hemothorax, infection, irregular heart beat, mediastinal widening, perforation, pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage.</p> <p>See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.</p> <p><b>Caution:</b> Federal law (United States) restricts these devices to sale by or on the order of a physician.</p> <p>MAJ_83037</p>

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Customer Care Team