Product event summary: the data files and sheath, 4fc12 with lot number 10375 were returned and analyzed.The data files showed multiple injections performed with an unrelated catheter without any system notices.Visual inspection of the sheath showed the shaft was kinked 2.47 inches from the tip.Functional testing indicated the reported deflection angle problem with the sheath was not reproducible and deflection worked as per specification.Dissection did not show any breakage of the pull wire.In conclusion, the sheath failed the return product inspection due to a shaft kink.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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