INTENDED USE / INDICATIONS FOR USE
The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neurovasculature to temporarily stop or control blood flow and for balloon assisted embolization of aneurysms.
CONTRAINDICATIONS
None known.
WARNINGS
•Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Stryker Neurovascular representative.
•For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
•After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
•These devices should only be used by physicians who have received appropriate training in neurointerventional surgery, interventional neuroradiology or interventional radiology.
•Use only with appropriate inflation media (of saline and contrast solution mixture). Do not use oil-based contrast agents such as Lipiodol® or Ethiodol®. Use of these contrast agents can damage the balloon. •The compatibility of the TransForm Occlusion Balloon Catheter has not been evaluated with polyvinyl alcohol (PVA) particles or n-butyl cyanoacrylate (n-BCA).
•The balloon catheter is not intended to be used as an infusion catheter, for embolectomy or subselective angiography. The balloon may inadvertently inflate if used for these types of procedures. •Presence of implanted devices such as clips and stents, and anatomical structures or irregularities such as bone fragments or calcifications, may damage the balloon or prevent entry/removal. •Do not steam shape the catheter tip, as heat may damage the balloon material.
•The balloon should never be inflated or deflated with a pressure-based inflation device.
•Carefully inspect the balloon catheter prior to use. If product is damaged do not use and contact your Stryker Neurovascular representative. Use of a damaged catheter may cause serious injury. •Verify device size, configuration and patient conditions are suitable for the specific procedure.
•Prior to introducing the balloon catheter system into the vasculature purge the system carefully to avoid accidental introduction of air into the balloon catheter system. Failure to do so may release trapped air during device use and cause neurological deficits. Do not perform initial balloon flush while in the vasculature.
•Never advance or withdraw the balloon catheter system against resistance. Movement of device against resistance could dislodge a clot, perforate a vessel wall, or damage the device. If resistance is felt when advancing or removing the balloon catheter from the guide catheter, carefully remove them as a unit to prevent damage to the blood vessel, guide catheter or the device.
•Do not inflate the balloon beyond the diameter of the vessel being treated or beyond the maximum allowed inflation volume (see tables 2-4). Excessive inflation volume may result in a ruptured balloon or damage to the vessel. Do not move the balloon catheter while the balloon is inflated.
•Withdrawing the guidewire into the balloon catheter past the distal tip (e.g., in-vivo guidewire exchange, flushing the balloon, etc.) is not recommended due to the risk of blood entry into the balloon. Blood in the balloon may result in risk of serious injury due to poor balloon visualization and the potential of flushing embolic clots. If the guidewire is withdrawn into the balloon catheter past the distal tip, withdraw the entire balloon catheter system. Prior to reintroduction, prepare the balloon catheter system per the directions in the Prepare Occlusion Balloon Catheter steps.
