(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event: estimate.Evaluation summary: visual inspections were performed on the returned device.The tip detachment was confirmed.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 revealed no other incidents.The investigation was unable to determine a cause for the reported tip detachment.It may be possible that during the attempt to load the backload the guide wire, the tip and guide wire were not properly aligned causing the noted damage and separation of the tip; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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