(b)(4).The device was not returned for analysis.The balloon rupture could not be confirmed.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 incidents.The investigation determined that the reported balloon rupture and subsequent patient effects appear to be 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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