(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and dimensional inspections were performed.The reported shaft separation and kink were confirmed.The reported difficulty positioning the device in 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear 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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