BEUDAMED
    FDA Adverse Event Other Summary report: N

    7F FRCEZOR CARDIAC CRYOABLATION CATHETER

    MDR report key: 620659 · Received July 13, 2005

    Report

    Report Number
    3002648230-2005-00001
    Event Type
    Other
    Date Received
    July 13, 2005
    Date of Event
    June 16, 2005
    Report Date
    July 12, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PRELIMINARY INFORMATION PROVIDED IN THE CASE REPORT FORM SEEMED TO INDICATE A PT WITH PREVIOUS FAILED RF TREATMENT FOR WPW WAS TREATED WITH CRYO ENERGY TO AN ACCESSORY PATHWAY. THE HEART BLOCK RESOLVED COMPLETELY AFTER 30 HOURS AND THE PT WAS SUBSEQUENTLY DISCHARGED FROM HOSPITAL. NO LESS OF DELTA WAVES DURING THE FIRST 7 CRYOMAPPING, IN CRYOMAPPING NUMBER 8, A 3RD DEGREE AV-BLOCK WAS RECORDED WITH TEMPERATURE AROUND -32 DEGREE C. INJECTION WAS STOPPED BUT CONDUCTION DIDN'T RECOVER. CONDUCTION WAS PRESENT OVER THE ACCESSORY PATHWAY. THE PT WAS SENT TO ICU FOR MONITORING FOR THE NEXT 24 HOURS. THE INJURY IS CONSIDERED SERIOUS BECAUSE OF PROLONGATION OF HOPITALISATION FOR MONITORING. AN EXPERT MEDICAL OPINION FROM CRYOCATH'S MEDICAL ADVISOR INDICATED THAT THE CATHETER MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. EVEN THOUGH THE CATHETER DID NOT MALFUNCTION, AND WAS USED CONSISTENT WITH ITS APPROVED LABELING. THE INTENDED USE IS ABLATION CARDIAC ARRHYTHMIAS. CRYOCATH TECHNOLOGIES CONCLUDED THAT THIS INCIDENT IS TO BE REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7F FRCEZOR CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR DEVICE (CATHETER) NFC CRYOCATH TECHNOLOGIES, INC. 207F3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization