6215 | Medtronic

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Indications, Safety, and WarningsIndicationsThe venogram balloon catheter is indicated for use within the coronary sinus. It is intended for infusing contrast solutions into the coronary vasculature for venogram imaging.  Contraindications The venogram balloon catheter is contraindicated for patients with a known allergy to latex or contrast medium. Warnings and precautions

This device is provided sterile and is for single use, for one procedure only. Reprocessing, resterilization, or reuse may compromise the structural integrity of this device or create a potential risk of patient or user infections due to the use of a contaminated or unsterile device.

Do not exceed the recommended maximum balloon inflation volume. Exceeding this volume will not appreciably increase the diameter of the balloon and will increase the probability of balloon rupture.

Do not use liquids as a balloon inflation medium. This impacts catheter performance and the ability to deflate the balloon.

Do not inject contrast solution into the infusion port if blood cannot be aspirated, to avoid pulmonary extravasation.

Although diagnostic cardiac catheterization procedures have proven to be safe, certain complications can occur. It is recommended that the user of this product become familiar with the evidence-based guidelines for the safe use of the venogram balloon catheter.

Use the Attain Clarity™ venogram balloon catheter only with compatible guide catheters. No test data is available to demonstrate compatibility of Attain Clarity™ venogram balloon catheter with non-Medtronic guide catheters.

Do not use alcohol to wipe or flush the catheter because the balloon may be damaged.

Potential complications Potential complications related to the use of the venogram balloon catheter include, but are not limited to, the following patient-related conditions: air embolism, allergic reaction to contrast media, bleeding at the insertion site,  brachial plexus injury, cardiac tamponade,  dissection, endocarditis, hematoma formation, hemothorax, infection, irregular heartbeat, perforation, pneumothorax, subclavian artery puncture, thrombophlebitis, thrombosis, valve damage, vascular occlusion, vessel damage. Other potential complications related to the venogram balloon catheter include, but are not limited to, the following: balloon rupture, catheter kinking.See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician. MAJ_85823

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