Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.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.The investigation was unable to determine a cause for the reported balloon rupture.It is possible that the balloon rupture was the result of interaction with the lesion and/or associated devices causing damage to the outer surface of the balloon material which subsequently ruptured during inflation; however, this could not be confirmed.The noted separation may be the result of the ruptured balloon material catching on the introducer sheath during removal.The removal of foreign body was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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