C315S10

Indications, Safety, and WarningsIndications (or intended use)The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.ContraindicationsUse of the C315 percutaneous catheter is contraindicated in patients with obstructed or inadequate vasculature.Warnings and Precautions

This device is intended only to be used once for a single patient. Do not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device that could result in patient injury, illness, or death.

Keep external defibrillation equipment nearby for immediate use during insertion, placement, acute lead system testing, or whenever arrhythmias are possible or intentionally induced. Backup pacing should be readily available during implant. Use of a delivery system and/or leads may cause heart block. For further information about this and other potential adverse events or complications, refer to the technical manual packaged with the appropriate product.

Use care when passing a catheter through vessels and tissue. Avoid damage, such as perforations and dissections, to vessels and cardiac tissue, during catheter passage and positioning. Do not push, pull, or rotate the catheter against resistance. If resistance is met, discontinue movement, determine the reason for resistance, and take appropriate action before continuing. Damage to the catheter may prevent it from performing with accurate torque response and control, and may cause vessel damage.

Use the catheter only with compatible transvenous devices. No test data is available to demonstrate compatibility of any non-Medtronic device with the catheter. Consequences of using the catheter with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device or catheter during delivery. Slitting evaluations on this product were conducted using Medtronic Universal II or Medtronic Adjustable Slitters. These are the only slitters recommended for use with the C315 catheter.

Handle the catheter with care at all times. Do not kink, stretch, or severely bend the catheter. Do not use surgical instruments to grasp the catheter. Do not use excessive force when inserting a catheter into a vessel. Ensure the catheter is thoroughly flushed and free of air prior to use. Avoid contact with liquids other than blood, saline, or contrast solution. Use in conjunction with fluoroscopic guidance and proper anticoagulation agents.

Use the side port on the hub to flush the catheter. The catheter must be thoroughly flushed and free of air prior to use. When using the side port, consider sealing the proximal opening of the hemostatic valve with a thumb or forefinger.

Potential Adverse Events or Potential ComplicationsAir 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.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.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_82958

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