(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.The reported tip kink was able to be confirmed.Additionally, a radial tear was noted proximal to the distal end of the tip.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after sheath and stylet removal inadvertent mishandling of the device resulted in the reported kinked tip and the noted torn tip.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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