INDICATIONS, SAFETY, AND WARNINGS CRT Delivery Systems


Attain Command + SureValve Guide Catheters for Left Heart Delivery, Attain Select II + SureValve Delivery Catheter System

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.

The Attain Select II + SureValve delivery catheter system is indicated for the delivery of contrast medium and transvenous devices to the coronary sinus and left-heart venous anatomy. The delivery catheter system is indicated for use with outer guide catheters.

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.

For Attain Select II + SureValve delivery catheter system, use of the delivery catheter system is contraindicated in patients with obstructed or inadequate vasculature.

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. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com

Caution:  Federal law (USA) restricts these devices to sale by or on the order of a physician.


Attain Deflectable Catheter Delivery System

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 French), with the exception of the 2.3 mm (7.0 French) 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 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 (USA) restricts these devices to sale by or on the order of a physician.


Attain Venogram Balloon Catheter Model 6215

Indications

The 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 intended to be used only once for a single patient. Reuse, reprocessing, or resterization 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.
  • Do not exceed the recommended maximum balloon inflation capacity. Exceeding this volume will not appreciably increase the diameter of the balloon and will increase the probability of balloon rupture.
  • Use only filtered carbon dioxide to inflate the balloon, if there is a possibility that balloon rupture would result in air embolism in the left side of the heart or systemic circulation.
  • Do not use liquids as a balloon inflation medium.
  • Do not inject contrast solution into the infusion lumen if blood cannot be aspirated, to avoid pulmonary extravasation.
  • Although diagnostic cardiac catheterization procedures have proven to be safe, certain complications can occur, and it is recommended that the user of this product become familiar with the guidelines established by Drs. Swan and Ganz for the safe use of the venogram balloon catheter.1
  • Do not use forceps on the catheter. Perforations, arteriovenous fistula formation, and other vascular trauma have been reported with the use of vascular catheters.
  • Complications may develop during any catheterization procedure.

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, allergic reaction to latex, arteriovenous fistula formation, bleeding at the insertion site,  brachial plexus injury, cardiac tamponade, dissection, endocarditis, hematoma formation, hemothorax, infection, irregular heart beat, 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 knotting.

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 (USA) restricts these devices to sale by or on the order of a physician.


Attain Clarity Venogram Balloon Catheter Model 6225

Indications

The venogram balloon catheter is indicated for use within the coronary sinus; it is intended for infusing contrast solutions into the coronary vasculature for occlusive venogram imaging.

Contraindications

The venogram balloon catheter is contraindicated for patients with a known allergy to 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 only with compatible guide catheters. No test data is available to demonstrate compatibility of Attain Clarity 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 heart beat, 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. For further information, please call Medtronic at 1-800-328-2518 and/or consult theMedtronic website at www.medtronic.com.

Caution:  Federal law (USA) restricts these devices to sale by or on the order of a physician.


Attain Hybrid Guide Wires

Indications

The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

Contraindications

The guide wire is not intended for use in the cerebral 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.
  • Prior to use and, when possible during the procedure, inspect the guide wire carefully for bends, kinks, coil separations, or other damage. Do not use a guide wire that is damaged. Damage may prevent a guide wire from performing with accurate torque response and control, and may cause vessel damage.
  • Upon guide wire introduction, ensure that the lead tip is free to move within the blood vessel and is not pointed toward the vessel wall. Improper position could result in vessel damage when the guide wire exits the lead.
  • Always maintain visualization of the guide wire under fluoroscopy, ensuring that the tip is moving freely when torque is applied. If the tip is not rotating freely, never turn the guide wire 360° in the same direction.
  • Do not push, pull, or rotate the guide wire against resistance. If resistance is met, discontinue movement of the guide wire, determine the reason for resistance, and take appropriate action before continuing. Do not use excessive force or surgical instruments when inserting the guide wire into the lead. Avoid overbending or kinking the guide wire. Do not expose the guide wire to organic solvents. Exercise care while handling guide wires to help prevent the possibility of coil separation, uncoiling, kinking, or breakage.

Potential Complications

Potential complications related to the use of the guide wire include, but are not limited to, the following: air embolism, cardiac perforation, coronary sinus dissection, coronary sinus perforation, heart block.

See the device instructions for use for detailed information regarding the procedural instructions, indications, contraindications, warnings, precautions, and potential complications/adverse events. Because the guide wire is a functional extension of the lead, review the lead documentation for all appropriate warnings, complications, precautions, and instructions. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.

Caution:  Federal law (USA) restricts these devices to sale by or on the order of a physician.


Worley Advanced Implant Tools

Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principles, clinical applications, and associated risks is necessary before performing the procedure. Prior to use, please review the device instructions for use for detailed information regarding 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 (USA) restricts these devices to sale by or on the order of a physician.


1

Swan HNC, et al. N Engl J Med. 1970;283:447-451.