(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
(b)(4).
Evaluation summary: visual and functional inspections were performed on the returned device.
The reported kink and separation were confirmed; however, the reported difficulty positioning the device was not.
A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.
Additionally, a review of the complaint history identified no other incidents from this lot.
It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: if resistance is felt, determine the cause before proceeding.
Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.
The investigation determined the reported kink and shaft separation appear to be related to user error; however, the difficulty positioning the bdc appears to be related to operational context.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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