BEUDAMED
    FDA Adverse Event Other Summary report: N

    7F FREEZOR CARDIAC CRYOBLATION CATHETER

    MDR report key: 622864 · Received July 27, 2005

    Report

    Report Number
    3002648230-2005-00002
    Event Type
    Other
    Date Received
    July 27, 2005
    Date of Event
    June 27, 2005
    Report Date
    July 26, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CRYOBLATION OF ATRIAL TACHYCARDIA CLOSE TO HIS BUNDLE, WITH BRIEF CRYOMAPPING AND ONE 4 MINUTES CRYOBLATION RESULTING IN SUCCESS. TESTING WITH A 30 MINUTES POST ABLATION WAITING PERIOD SHOWED NO INDUCIBLE TACHYCARDIA. POST PROCEDURE, THE PT SUFFERED A CARDIAC TAMPONADE AND WAS SUCCESSFULLY STABILIZED. THE PHYSICIAN DID NOT BLAME THE CRYOCATHETER FOR PERFORATION, STATING TAMPONADE "IS INHERENT RISK OF ELECTROPHYSIOLOGY". THE PT ALSO STATED THAT ALTHOUGH THE PT REQUIRED TREATMENT AND HOSPITALIZATION, THE PT WAS EXPECTED TO MAKE A 100% RECOVERY. THE DEVICE DID NOT MALFUNCTION. CONTRIBUTION BY CATHETER IS UNLIKELY BUT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7F FREEZOR CARDIAC CRYOBLATION CATHETER CARDIOVASCULAR CAVICE (CRYOCATHETER) NFC CRYOCATH TECHNOLOGIES, INC. 207F3 40903

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening