(b)(4).The additional nc trek devices are being filed under separate medwatch reports.Evaluation summary: visual inspection was performed on the returned device.A separation, a kink and multiple bends throughout the hypotube were noted during return analysis.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 noted shaft separation; however, the noted kink and bends appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Reportedly, there was an issue with three nc trek balloon dilatation catheters; however, there was no information available.No adverse patient effects were reported.No additional information was provided.The return device analysis of the three nc trek catheters found the following: the 3.5x8mm nc trek: the outer member was stretched and torn at the proximal seal.The 3.75x12mm nc trek: the outer member was stretched at the proximal seal.The 2.75x20mm nc trek: the hypotube was separated.
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