Product event summary: the sheath, 4fc12 with lot number 92041, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.Flushing/ air aspiration testing did not show any air passing though the tube or expelled from the distal tip.Functional testing of the sheath confirmed the hemostatic valve was leaking.Air bubbles were observed through the valve.The valve disk was suspected to be torn.In conclusion, the air ingress during aspiration 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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