Indications, Safety, and Warnings
Indications
The deflectable catheter delivery system 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.
Contraindications
Use of the deflectable catheter delivery system is contraindicated for right ventricular use in patients with tricuspid valvular disease or a mechanical tricuspid heart valve. Use of the deflectable catheter delivery system is contraindicated in patients with obstructed or inadequate vasculature.
Warnings and precautions
The deflectable catheter delivery system is for single use only and is not intended to be resterilized.
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. No test data is available to demonstrate compatibility of transvenous devices larger than 2.1 mm (6.2 Fr), with the exception of the 2.3 mm (7.0 Fr) deflectable catheter dilator included in this 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.
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. Do not use excessive force when inserting a deflectable catheter into a vessel. Do not wipe the deflectable catheter with chlorofluorocarbon-based solvents. Ensure the deflectable catheter is thoroughly flushed with saline and free of air prior to use to avoid air embolism to the patient. Avoid contact with liquids other than isopropyl alcohol, blood, saline, or contrast solution.
Use care when passing the deflectable catheter through vessels and tissue. Avoid damaging vessels and cardiac tissue, such as perforations and dissections, during deflectable catheter passage and positioning. Remove the dilator after the deflectable catheter assembly has been advanced into the right atrium to minimize the risk of perforation. Straighten the distal section as much as possible before removing the deflectable catheter from the patient to avoid vessel damage during removal.
Keep the cutting surface of the slitter in line with the hub and catheter shaft axis. Do not move the catheter or slitter in a back-and-forth motion. This ensures that the hub and guide catheter wall are cleanly slit by the slitter blade, preventing transvenous device damage and/or dislodgements.
Use the introducer valve to impede the backflow of venous blood during the implant procedure. Ensure that the side-port stopcock is closed before attaching the valve to the deflectable catheter hub. The side-port is for flushing the deflectable catheter only. Do not infuse through the side-port. When using the side-port, consider sealing the proximal opening of the introducer valve with a thumb or forefinger.
Use the side-port on the introducer valve to flush the deflectable catheter. The deflectable catheter must be thoroughly flushed and free of air prior to use. Do not use a power injection syringe to inject contrast solution.
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 the deflectable catheter delivery system and/or transvenous devices may cause heart block.
Potential complications
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 heartbeat, 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.
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
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