Visual and functional inspections were performed on the returned device.The reported failure to fold was confirmed.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported failure to fold; however, the reported difficulty removing the device from the guiding catheter appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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