Product event summary: the data files and sheath, 4fc12 with lot number 79166 were returned and analyzed.The data files showed at least 15 applications were performed with a balloon catheter on the date of the event with no system notices or 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, the reported issue 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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It was reported that during a cryo ablation procedure, as a radiofrequency catheter was inserted in the sheath and touch-up was performed, it was observed that blood was leaking from the hemostatic valve.As the blood leaking was more than expected, the sheath was replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.
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