The device was returned for analysis.The reported rupture was confirmed.There were noted kinks on the working length of the balloon and inner member.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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It is possible the rupture occurred during interaction of the lesion/ anatomy or associated devices.The noted kinks on the device are likely due to case circumstances.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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