Product event summary: the sheath, 4fc12 with lot number 46137, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced during the pressure test when the dilator was introduced through the sheath.The hemostatic valve was leaking, the valve disk was suspected to be torn.In conclusion, the reported air ingress/ valve leak was confirmed through testing.The 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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