Product event summary: the sheath 4fc12 with lot number 0010314850 was returned for analysis.Visual inspection of the sheath showed the shaft was kinked and twisted between 1.29 to 2.43 inches from the tip.The distal tip and dilator tip of the sheath were intact, no fractures, breaks, or kinks noticed.No teflon delamination noticed at the tip of the sheath shaft.Functional testing of the sheath showed deflection worked as per specification.The kink was preventing smooth steerability when a test balloon catheter was inserted.In conclusion, the sheath failed the returned product inspection due to the shaft kink and twist near the tip.If information is provided in the future, a supplemental report will be issued.
|