BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2003740 · Received February 24, 2011

    Report

    Report Number
    3002648230-2011-00008
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. IT WAS DISCARDED AFTER THE PROCEDURE SINCE NO MALFUNCTION OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED USING AN ARCTIC FRONT CATHETER. ALL FOUR PULMONARY VEINS WERE ABLATED USING STANDARD TECHNIQUES. THE PT WAS INTUBATED DURING THE PROCEDURE. AFTER REMOVAL OF THE ARCTIC FRONT CATHETER, RF ABLATION WAS USED TO COMPLETE THE PROCEDURE. THE PT HAVING AN INTERNAL DEFIBRILLATOR, WAS NOTED IN A RHYTHM NEEDING FURTHER ABLATION OF THE AV NODE. APPROX 1 HOUR TO 1.5 HOURS AFTER BEING TRANSPORTED TO HER ROOM, THE PT BECAME NAUSEATED AND SHORT OF BREATH. A CHEST X-RAY WAS DONE AND IT WAS FOUND THAT THE PT HAD A RIGHT SIDED HEMOTHORAX REQUIRING CHEST TUBE INSERTION. THE PT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF282 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Disability