H-6 results: the detached needle was not returned for evaluation, therefore, a thorough evaluation of the device could not be performed. H-6 conclusion: one actual sample package containing a double armed assembly but only one attached needle was submitted for evaluation. The needle was inspected for swage attribute defects. There were none. The suture insertion end was evaluated for evidence of suture clip-off. The suture appears to have been clipped off but there was no needle returned to verifty representative samples of the returned product were tested for needle pull tensile strength and the results obtained were above the ethicon requirements, which always equal or exceed the minimum usp requirements. Once a needle pull off occurs, the typical method to continue with the anastomosis would be to hold the loose end of suture and begin suturing with antoher strand adjacent to the first. The two strands are then tied together and the anastomosis is completed. Alternatively, the surgeon who is using a double-armed suture can complete the anastomosis from the opposite direction, and tie the two ends of the same strand together. Thus avoiding the need to take down and redo the anastomosis. The fact that the patient is having a redo operation indicates that this patient has a tendency to stenose or occlude the anastomosis regardless of how well the anastomosis was performed.

It was reported that during a "redo" cabg procedure, the suture detached from the needle while the surgeon was completing an anastomosis of a distal vein. The entire anastomosis needed to be redone. Since this was a "redo" case not much space was available. As a result, there was increased tissue trauma due to the resuturing and surgeon thought the quality of the anastamosis was poor. Reportedly, the patient experienced excessive post operative bleeding related to this and the hospital stay was increased by approximately one week. Surgery was delayed by 45 minutes. The current status of the patient is unknown.