Product event summary: the sheath 4fc12 with lot number 0010121529 was returned and analyzed.Visual inspection of the sheath showed the shaft was kinked and twisted between 2.00 to 2.74 inches from the tip.The kink was preventing smooth steerability when a test balloon catheter was inserted.Functional testing of the sheath showed that the reported problem was not reproducible, and the deflection worked as per specification.Dissection did not show any breakage of the pull wire.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.
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