It was reported that during a cryo ablation procedure, air was continuously removed from the side port of the sheath.Additionally, resistance was noted upon insertion of the balloon catheter into the sheath.The sheath was replaced.It was also reported that there was an issue during pre-inflation, and the balloon catheter had to be manipulated to get it back to normal for insertion.The case was completed with cryo.After the case, when checked, it was then observed that the hemostatic valve of the sheath was slightly split.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 37413 were returned and analyzed.The data files showed ten injections were performed with a balloon catheter and showed the temperature not dropping as expected and inflation was not sustained at many injections.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 and the valve disk was suspected to be torn.In conclusion, the air ingress during aspiration was confirmed through testing.The sheath failed the return 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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