Indications, Safety, and Warnings
Indications (or Intended Use)
This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.
Contraindications
The delivery system is contraindicated for use in the following situations:
In patients with obstructed or inadequate vasculature for venous access.
In patients with a mechanical tricuspid heart valve for placement of a lead in the right ventricle.
Warnings and Precautions
Transvenous Device compatibility – Use the delivery system only with compatible transvenous devices and compatible leads. No test data is available to demonstrate compatibility of the catheter with any device not manufactured by Medtronic. 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.
Single use – The delivery system is for single use only and is not intended to be resterilized or reused. Reuse, reprocessing, or resterilization may compromise the structural integrity of the product or create a risk of contamination of the product, which could result in patient injury, illness, or death.
Sterile package inspection – Before opening the sterile package, visually check for any signs of damage that might invalidate the sterility of the contents. If the package is damaged, contact a Medtronic representative.
Storage conditions – There are no special handling, including no special storage conditions, required for this device. Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place.
“Use-by” date – Check to verify that the product is within the expiration date. Do not use the product after the “Use-by” date on the package label.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. Do not clean or resterilize the delivery system. Dispose of the product after use according to local environmental requirements.
Handling the catheter – Handle the catheter and dilator with care at all times.
Do not kink, stretch, or severely bend the catheter.
Do not use surgical instruments to grasp the catheter shaft.
Do not use excessive force when inserting a catheter into a vessel.
Before use, ensure that the catheters are thoroughly flushed with saline or heparinized saline and free of air to avoid air embolism to the patient.
Avoid contact with liquids other than blood, saline, heparin, or contrast solution.
Vessel and tissue damage – Use care when passing a catheter through vessels and tissue. To avoid damaging tissue or the tip of the catheter assembly, keep the catheter dilator fully inserted into the catheter during passage to the right atrium. 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.
Flushing the delivery system – The catheters and dilators must be thoroughly flushed and free of air before use. Do not use a power injection syringe to inject contrast solution.
Necessary hospital equipment – 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, leads, or both 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.
Perforation – 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.
Review the lead documentation – Because the delivery systems are used in the lead implantation procedure, it is recommended that the lead documentation be reviewed for all appropriate warnings, complications, and precautions.
Small-bore connectors – This medical device uses an alternative small-bore connector design different from those specified in the ISO 80369 series. Because of this, there is a possibility that a misconnection could occur between this medical device and a medical device using a different or alternative small-bore connector. Such a misconnection could result in a hazardous situation that could potentially cause harm to the patient. Special measures need to be taken by the user to mitigate these reasonably foreseeable risks.
Potential Adverse Events or Potential Complications
Potential complications include, but are not limited to air embolism, allergic reaction, cardiac inflammation, cardiac perforation, cardiac valve damage, embolism, infection, lead dislodgement, pericardial effusion, physical injury, subclavian artery puncture, thrombosis, hemorrhage, hemothorax, tissue trauma, vascular tear.
See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 800-328-2518 and/or consult Medtronic’s website at www.medtronic.com .
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
MIN_92423
Medtronic™ rotatable connector 5944RL
SelectSecure™ pacing lead
