Event summary: the patient data files showed at least four injections were performed with catheter 2af284 / 17118-53 on the date of the event without any triggered system notice, data files also showed at least another seven injections were performed with catheter 2af284 / 99242-49 on the date of the event without triggered any system notice.The failure file showed the following system notices have been triggered on the date of the event: #50011 ¿the refrigerant delivery path is obstructed¿; #50012 ¿the refrigerant delivery path is obstructed¿; #50034 ¿the safety system has detected a compromised outer vacuum¿; #50007 ¿the safety system has detected fluid in the console.The system is inoperable¿; #50008 ¿the system has detected a software error and stopped the injection;¿ #50009 ¿the system has detected a failure¿; #50013 ¿the refrigerant level is too low to continue¿; #50014 ¿the balloon is not sufficiently inflated; balloon inflation pressure was not reached in time¿; #50017 ¿the operational temperature of the system is high preventing proper operation¿.#50035 ¿the balloon is deflated¿; #12222 ¿the system detected a refrigerant leak during balloon inflation¿.Upon visual inspection of flexcath sheath 4fc12 / 92497-088, results showed the shaft was kinked 60 mm from the tip.Air aspiration was reproduced when a lab test catheter was introduced through the sheath.Dissection showed the hemostatic valve was leaking.In conclusion, the reported air ingress issue was confirmed through testing but not confirmed through the data analysis.The sheath failed the returned product inspection due to a kink at shaft and a leaking hemostatic valve.A good faith effort will be made to obtain the applicable information relevant to the report.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, after the balloon catheter was inserted into the sheath, air was continuously introduced during aspiration.The issue persisted when air aspiration was performed again.The sheath was replaced without resolve.The balloon catheter was replaced with resolve.The physician suspected that the balloon catheter was larger than normal.The case was completed with cryo.No patient complications have been reported as a result of this event.
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