(b)(4).Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported kink and separation were confirmed.The reported difficulty to position and difficulty removing the device 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 identified no other incidents from this lot.The investigation determined the reported difficulty positioning and retracting the device and separation appear to be related to user error; however, the reported kink and additional treatment appear to be related to operational context.It should be noted the nc trek instructions for use (ifu) states: prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.Additionally, the warning section of the ifu 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.It is possible that the ifu violations caused and contributed to the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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