Product event summary: the sheath, 4fc12 with lot number 04482, was returned and analyzed.Visual inspection of the sheath showed the device kinked on the side port tube before the handle.Deflection worked as per specification.Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.The hemostatic valve was leaking, and the valve disk was suspected to be torn.In conclusion, the reported leak issue was confirmed through testing.The sheath failed the returned product inspection due to the kink of the side port tube and a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
|