Product event summary: the data files and sheath with lot number 10833, were returned and analyzed.The data files showed at least thirteen applications were performed with a balloon catheter on the date of the event with no system issues.Visual inspection of the sheath showed the device was intact with no apparent issues.Flushing/ air aspiration testing did not show any air passing through 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, air ingress 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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