The device was returned for analysis.The reported break was able 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.As there was no damage noted to the device during the inspection prior to use, 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 anatomy and/or inadvertent mishandling resulted in the noted device damages (multiple sheath chatter marks on its entire length, wrinkled sheath, kinked i-beam, multiple jacket and inner member bends ) and resulting in the reported/noted shaft break, thus preventing the shaft lumens from moving freely ultimately resulting in the reported difficulty deploying the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.E1: address 1.
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