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