(b)(4).The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.Evaluation summary: a visual and functional inspection was performed on the returned device.The reported loose or intermittent connection was unable to be confirmed.The reported physical property issue/damages was able to be confirmed as there were cracks noted in the hub.Additionally when the device was pressurized, fluid leaked out of the cracks in the hub.As there was contrast in the inflation lumen consistent with preparation, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during preparation the inflation device was over torqued during connection to the hub resulting in the noted flash and cracks on the hub (reported physical property issue) thus resulting in the reported loose or intermittent connection.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 incidents from this lot.There is no indication of a product quality issue with respect to design, manufacture or labeling.
|