The device was returned for analysis.The reported mechanical jam was unable to be confirmed.The reported activation failure was 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 interaction with the mildly tortuous anatomy and/or inadvertent mishandling resulted in the noted device damages (bunched/wrinkled sheath, bunched jacket stabilizer, multiple jacket stabilizer bends/kinks) thus resulted in preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent.The noted stent damages occurred due to interaction with the guiding catheter sheath during removal.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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