CONTRAINDICATIONS
There are no known contraindications for this device.
WARNINGS
For Single Use Only! Single-use devices are designed and tested for only one patient application. These are disposable devices and are not designed for reprocessing and reuse. Reuse of designated “single-use” devices creates a risk of patient or user infections due to prior patient use and the difficulty in cleaning the narrow structures at material interfaces following direct blood contact. Contamination or reprocessing cleaning agent residues may lead to adverse patient reactions and may damage the device. Use of non-Abbott Medical packaging may compromise device functionality and sterility due to compromised protection from shipping and handling damage. The absence of labeling after reprocessing, may lead to misuse of the device and impaired traceability. Reprocessing and reuse may result in patient or user injury, permanent impairment or death.
COMPLICATIONS
Procedures requiring percutaneous catheter/guidewire introduction should not be attempted by physicians unfamiliar with the possible complications. Complications may occur during certain procedures but may not be limited to air embolism, hematoma formation, sepsis/infection, excessive bleeding, vessel damage.