The device was returned for analysis.The reported premature activation was able to be confirmed.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement the guiding catheter and the device were not coaxially aligned resulting in the reported difficult to advance and the reported difficult to remove.Interaction and/or manipulation of the device resulted in the noted device damages (multiple distal sheath wrinkles, wrinkled jacket stabilizer) compromising the device resulting in the distal sheath to slightly retract from the base of the tip, and thus inadvertently resulting in the reported/noted stent premature activation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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