Event summary: upon visual inspection of the flexcath sheath 4fc12 / 64371-068, results showed the device was intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.We suspect the valve disk is torn.In conclusion, the reported issue air ingress during aspiration 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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