Product event summary: the sheath was returned and analyzed.Visual inspection of the reported sheath 4fc12 33736 showed the device was intact with no apparent issues.Air aspiration was reproduced during the pressure test when the test dilator was introduced through the sheath.Additionally, the hemostatic valve was leaking, and it was suspected that the valve disk was torn.In conclusion, the reported air ingress issue was confirmed through product analysis.The reported sheath failed the returned product inspection due to a leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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