(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Failure to follow steps/instructions.The device was not returned for evaluation.It should be noted that the coronary dilatation catheters, nc trek rx, instruction for use, states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported kink; however, the shaft separation appears to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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