(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned.Visual and functional inspections were performed.The reported difficult to position over the guide wire was unable to be confirmed due to the condition of the device.The reported difficulty to remove 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 similar incidents reported for this lot.The investigation was unable to determine a conclusive cause for the reported difficult to position over a guide wire.The reported difficulty to remove the guide wire and subsequent damages to the device appears to be related to operation context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|