The device was returned for analysis.The reported difficult to remove was able to be confirmed.The reported deflation problem 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 inadvertent mishandling resulted in the noted multiple stretched outer member damages thereby reducing the inflation/deflation lumen; thus resulting in the reported deflation problem and the reported difficult to remove.Manipulation of the device in attempts to remove the device resulted in the noted device damages (folded balloon distal taper, stretched balloon inner member, proximal balloon marker was located at distal end of the proximal balloon seal, outer member tear/hole).The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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