(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and functional inspections were performed on the returned device.The inflation issue and irregular balloon fold was not confirmed.It may be possible that the kinked inner member contributed to the inflation issue while in the anatomy preventing the balloon from inflating; however, this could not be 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 of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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