(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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