INDICATIONS FOR USE
The ProTrack Microcatheter is intended to be used as an exchange guide for converting guidewires or as a standard infusion wire.
CONTRAINDICATIONS
The ProTrack Microcatheter is not recommended for use with any condition that does not require an exchange guide for converting guidewires or a standard infusion wire.
WARNINGS
Only physicians with a thorough understanding of angiography and percutaneous interventional procedures should use this device.
The ProTrack Microcatheter is supplied STERILE using an ethylene oxide process. Do not use if the package is damaged.
The ProTrack Microcatheter is intended for single patient use only. Do not attempt to sterilize and reuse the catheter. Reuse can cause the patient injury and/or the communication of infectious disease(s) from one patient to another. Failure to do so may result in patient complications.
Laboratory staff and patients can undergo significant x-ray exposure during interventional procedures due to the continuous usage of fluoroscopic imaging. This exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure. V.
PRECAUTIONS
Do not attempt to use the ProTrack Microcatheter before thoroughly reading the accompanying Instructions for Use.
Interventional procedures should be performed only by physicians thoroughly trained in the technique in a fully equipped catheterization laboratory.
The sterile packaging should be visually inspected prior to use to detect any compromise. Ensure that the packaging has not been damaged. Do not use the equipment if the packaging has been compromised. Visually inspect the catheter to ensure there is no cracking or damage to the insulating material. Do not use the equipment if there is any damage.
Do not use the ProTrack Microcatheter after the “Use By” date indicated on the label.
Careful catheter manipulation must be performed to avoid cardiac damage, or tamponade. Catheter advancement should be done under fluoroscopic guidance. If resistance is encountered, DO NOT use excessive force to advance or withdraw the catheter.
Do not bend or kink the catheter. Excessive bending or kinking of the catheter shaft may damage the integrity of the catheter and may cause patient injury. Care must be taken when handling the catheter.
This device is not intended to be advanced through the vascular system without fluoroscopic guidance.
Do not withdraw the ProTrack Microcatheter through a needle cannula.
Do not exceed the maximum recommended pressure of 250 psi (1.72 MPa).
Care must be taken to verify the dimensional compatibility of the ProTrack Microcatheter when used with other manufacturer’s devices.
Baylis Medical Company relies on the physician to determine, assess, and communicate to each individual patient all foreseeable risks of the ProTrack Microcatheter.
Individual patient anatomy and physician technique may require procedural variations.
