(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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