It was reported that during a cryo ablation procedure, liquid was observed dripping from the handle of the sheath.It was noted that the leak was coming from inside the sheath.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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Product event summary: the data files and sheath, 4fc12 with lot number 64371 were returned and analyzed.The data files showed at least eleven injections were performed with a balloon catheter on the date of the event with no issue.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was reproduced when a test balloon catheter was introduced through the sheath.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 air ingress issue was confirmed through testing but not through 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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