Event summary: upon visual inspection of sheath 4fc12/41670, results 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.The hemostatic valve was leaking.It was suspected that the valve disk was torn.In conclusion, the reported issue (air ingress) has been 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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