Product event summary: the data files and flexcath sheath 4fc12 with lot number 94312 were returned and analyzed.The data files showed at least 7 applications were performed with a balloon catheter on the date of the event with 50003 was triggered at application number 2, system notice 50012 was triggered at application number 3, and 50002 was triggered at application number 7.Visual inspection of the sheath showed the device was intact with no apparent issues.The flexcath distal tip was intact with no apparent issues no fracture and breakage or kink were noticed.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, the sheath failed the returned product inspection due to the leaking hemostatic valve.If information is provided in the future, a supplemental report will be issued.
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