BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREEZER XTRA SURGICAL CARDIAC CRYOABLATION DEV

    MDR report key: 625969 · Received August 12, 2005

    Report

    Report Number
    3002648230-2005-00004
    Event Type
    Other
    Date Received
    August 12, 2005
    Date of Event
    July 22, 2005
    Report Date
    August 11, 2005
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING CRYOABLATED FOR AVNRT, HAD PREVIOUSLY COMPROMISED AVN FUNCTION. DURING FAST INJECTION OF 25 SECONDS, CATHETER MAY HAVE MOVED ANTERIORLY AND THE PHYSICIAN OBSERVED A COMPLETE AV BLOCK. AFTER 5 MINUTES A TEMPORATRY PACEMAKER WAS INSERTED, AFTER 24 HOURS, PATIENT CONDUCTION RETURNED TO NORMAL SINUS RHYTM AND NO PERMANENT PACEMAKER WAS REQUIRED. THE ONSET OF THE COMPLETE AV BLOCK OCCURRED DURING A FAST INJECTION USING THE DEVICE ADJACENT TO AV NODE. THE DEVICE DID NOT MALFUNCTION. POSSIBLE CATHETER MOVEMENT DURING FAST INJECTION. THIS EVENT CONSTITUTES A SERIOUS INJURY BECAUSE THE ABLATION WAS TERMINATED EARLY AND FURTHER MEDICAL INTERVENTION WAS REQUIRED: TEMPORARY PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZER XTRA SURGICAL CARDIAC CRYOABLATION DEV CARDIOVASCULAR DEVICE (CRYOCATHETER) NFC CRYOCATH TECHNOLOGIES, INC. 227F5 #50112

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention