(b)(4).
Evaluation summary: visual and dimensional inspections were performed on the returned device.
The reported separation and kink were confirmed.
The reported difficulty positioning the bdc with the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.
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.
The investigation determined the reported kink/bend and separation appear to be related to circumstances of the procedure; however, a conclusive cause could not be determined for the reported difficulty positioning the bdc with the guiding catheter.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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