Product event summary: the injection proportional valve and valve board from the 106a3 console (b)(4) were returned and analyzed.During external visual inspection of the injection proportional valve it was observed that the returned part was intact with no apparent issues.The injection proportional valve was assembled to the test console following a warm-up time of 30 minutes, the console along with the test catheter failed the performance test due to the system notice 12221 "the system detected a high level of refrigerant flow during the system flush, and the system flush was stopped." further analysis through the cooling performance test showed that the injection pressure at pressure transducer 1 was not as expected and it was noted that the injection pressure value was not responding to proportional¿integral¿derivative control when the requested injection pressure was varied.During external visual inspection of the valve board, it was observed that the returned part was intact with no apparent issues.The valve board was assembled to the test console following a warm-up time of 30 minutes.The console along with the test catheter passed the performance test without any issues.The console passed multiple power test with no issues.In conclusion, the physical console was not returned, the injection proportional valve and valve board on the console were replaced in the field during servicing, the returned injection proportional valve was tested and confirmed defective, and the valve board was tested and confirmed functional.The product issue reported (system notice 50030) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.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, a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The console was restarted, the balloon catheter, electrical umbilical cable, coaxial umbilical cable and auto connection box were replaced which did not resolve the issue. the case was aborted and the patient was under general anesthesia.Service was performed at a later date. the injection proportional valve (mks) and the valve board were replaced which resolved the issue.The console was serviced as appropriate.No patient complications have been reported as a result of this event.
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