Indications, Safety, and Warnings
Indications
The Attain Command™ + SureValve™ left-heart delivery system is intended for introducing transvenous devices and leads into vessels of the left heart via the coronary sinus.
Contraindications
For Attain Command™ + SureValve left-heart delivery system, if the patient has obstructed or inadequate vasculature, for either venous access or in the coronary sinus, the left-heart delivery system is contraindicated.
Warnings
The delivery catheter system is for single use only and is not intended to be resterilized.
Use the delivery catheter system only with compatible transvenous devices. No test data is available to demonstrate compatibility of the catheters with any device that is not manufactured or distributed by Medtronic. Consequences of using the catheters with incompatible devices may include the inability to deliver the transvenous device or damage to the transvenous device during delivery.
Handle the catheters with care at all times. Do not kink, stretch, or severely bend the catheters. Do not use surgical instruments to grasp the catheter shaft. Do not use excessive force when inserting a catheter into a vessel. Ensure that the catheters are thoroughly flushed with saline or heparinized saline and free of air before use to avoid air embolism to the patient. Do not allow the catheter to come into contact with liquids other than blood, saline, or contrast solution.
Use care when passing a catheter through vessels and tissue. To minimize risk of perforation and dissection, 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.
Flush the catheters through the proximal end of the catheter. The catheters must be thoroughly flushed and free of air before 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. For information about potential adverse events or complications, refer to the product documentation packaged with the products chosen. Use of the catheters or transvenous devices may cause heart block.
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.
For Attain Command™ + SureValve™ left-heart delivery system, due to the relative stiffness of the catheter, damage to the walls of the vessels may include perforations or dissections. When in the right chamber of the heart, the guide-catheter dilator must be retracted within the outer guide catheter tip to minimize the risk of perforation.
Potential complications
Potential adverse events related to the use of the delivery catheter system include, but are not limited to, the following: 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.
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.
