Device code 2017 - contrast incorrect; incorrect prep visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was confirmed.A review of the lot history record identified multiple 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 one similar complaint from this lot.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use specifies that the contrast is 60% contrast medium diluted 1:1 with normal saline.Additionally, it should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.The investigation determined the noted stretching on the outer member distal to the midlap seal and reported deflation issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
|