The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.Based on the information provided, the difficulty to advance and subsequent balloon rupture appear to be due to case circumstances.It is likely that the device encountered resistance due to interaction with the heavily calcified and heavily tortuous lesion causing damage to the outer surface of the balloon material and resulted in the rupture.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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