Traxcess™ Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
Warnings and Precaution
Warnings:
The device should only be used by physicians who are familiar with angiographic and interventional procedures.
It is important to follow the instructions for use prior to using this product.
The guidewire is provided sterile and non-pyrogenic unless the unit package is opened or damaged.
The guidewire is intended for single use only. Do not resterilize and/or reuse the device. After use, dispose in accordance with hospital and/or local government policy.
Do not use if the packaging is breached or damaged.
Inspect the guidewire prior to use for any irregularities or damage and discard if noted.
The guidewire should be manipulated under fluoroscopic guidance.
Do not advance or withdraw the guidewire when excessive resistance is met until the cause of resistance is determined. Observe the tip response when turning the guidewire and avoid turning in the same direction more than three times when the tip is stationary. Avoid kinking the tip of the guidewire, as damage to the guidewire might occur.
Precautions:
Verify guidewire compatibility when using other ancillary devices commonly used in intravascular procedure.
Physician must be familiar with percutaneous, intravascular technique and possible complications associated with the procedure.
The guidewire has a lubricious surface and the distal platinum coil section should be hydrated prior to use.
Exercise care in handling the guidewire to reduce the chance of accidental damage.
Do not expose the guidewire surface to organic solvents such as alcohol or medications, which might damage the guidewire coatings and/or cause the guidewire to loose lubricity.
Verify that the inner diameter of any diagnostic or therapeutic catheter to be used with the guidewire is compatible with the outer diameter of the guidewire prior to use.
Potential complications include, but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, death, and thrombus formation.
Avoid repeated bending at the same point in order to avoid damage or separation of the guidewire.
Take precaution when manipulating the guidewire in tortuous vasculature to avoid damage to the guidewire.