BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREEZOR XTRA SURGICAL DEVICE

    MDR report key: 842086 · Received April 23, 2007

    Report

    Report Number
    3002648230-2007-00002
    Event Type
    Other
    Date Received
    April 23, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 23, 2007
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION, IT WAS DISCARDED AFTER THE CLINICAL CASE, AS NO MALFUNCTION OCCURRED DURING THE PROCEDURE. THE INFORMATION ON THIS ADVERSE INCIDENT WAS ONLY RECEIVED BY THE MANFACTURER (CRYOCATH TECHNOLOGIES) ON APRIL 13TH. THE CATHETER WILL NOT BE RETURNED TO MANUFACTURER FOR EVAL, AS NO MALFUNCTION WAS NOTICED DURING THE PROCEDURE, AND IT HAS BEEN DISCARDED ON SITE.

    Description of Event or Problem · 1

    PT CAME FOR A CRYOABLATION PROCEDURE. AFTER 18 SECONDS INTO FREEZE, THE RHYTHM WENT TO 3RD DEGREE BLOCK. THE RHYTHM DID NOT RECOVERE AND A TEMPORARY PACEMAKER WAS IMPLANTED. THE PT WAS MONITORED OVERNIGHT AND THE FOLLOWING DAY, AS THE HEART RHYTHM DID NOT RECOVERED, A PERMANENT PACEMAKER WAS IMPLANTED. THE PT WAS IN GOOD CONDITION DURING THE 3 DAYS HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA SURGICAL DEVICE CARDIOVASCULAR DEVICE NFC CRYOCATH TECHNOLOGIES, INC. 227F3 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| S