Product event summary: the data files were returned and analyzed.The data files showed system notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ in application 11 with balloon catheter 2af284 with lot number 53068.Data files showed at least 12 applications were performed with the catheter on the date of the event.The data files confirmed system notice #50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ on the date of the event.In conclusion, the product issue reported system notice 50005 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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