BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3153539 · Received June 8, 2013

    Report

    Report Number
    3002648230-2013-00087
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BIN FILES WERE REVIEWED AND SHOWED THAT AT LEAST 16 INJECTIONS WERE PERFORMED WITH THE CATHETER. BIN FILES ALSO SHOWED SYSTEM NOTICE MESSAGE 50013 ¿LOW REFRIGERANT¿ AT INJECTION 14. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC A POSSIBLE PHRENIC NERVE INJURY POST CRYOABLATION PROCEDURE. CHEST X-RAY REVEALED A RIGHT ELEVATED DIAPHRAGM THAT WAS NOT PRESENT PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257774 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other