BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2063712 · Received April 13, 2011

    Report

    Report Number
    3002648230-2011-00018
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    DURING A CRYOABLATION PROCEDURE USING THE ARCTIC FRONT CATHETER, AFTER ABLATING TWO PULMONARY VEINS, THE PHYSICIAN DECIDED TO STOP THE CRYOABLATION PROCEDURE AND TO SWITCH TO RF. UPON REMOVAL OF THE ARCTIC FRONT CATHETER, THE PT HAD A DECREASE IN BLOOD PRESSURE. THE PT DEVELOPED A PERICARDIAL EFFUSION AND SUBSEQUENTLY UNDERWENT A PERICARDIAL TAP THAT DRAINED 250CC OF FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF282 01051

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability