It was reported that during a cryo ablation procedure, air was continuously introduced from the hemostatic valve of the sheath.The hemostatic valve was suspected to be broken.The sheath was replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.
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Event summary: the patient data files showed at least thirteen applications were performed with catheter 2af284 / 24705-92 on the date of the event with no system issue.Upon visual inspection of flexcath sheath 4fc12 / 30513-084, 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.It was suspected that the valve disk was torn.In conclusion, the reported issue air ingress during aspiration has been confirmed through testing but not confirmed through the data analysis.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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