Medical device problem code updated.The reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The guidewire has the distal end fractured away, it was not returned.The device is deformed and has biological debris on it.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the wire is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, attempted correction of a damaged device, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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