BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2010906 · Received March 4, 2011

    Report

    Report Number
    3002648230-2011-00011
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER MARKETED IN THE US. HOWEVER, THE FREEZOR MAX CARDIAC CRYOABLATION CATHETER DIFFERS IN ITS INTENDED USE FROM THE FREEZOR MAX CARDIAC CRYOABLATION CATHETER MARKETED IN THE US. 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 PERFORMED IN (B)(6), THE PT GOT A PERICARDIAL EFFUSION WITH SICKNESS AND DROP IN BLOOD PRESSURE. WITH THE ADMINISTRATION OF PROTAMIN AND 1000 ML OF NACL, THE PT WAS STABLE. THE PT WAS TAKEN IN STABLE CONDITION TO INTENSIVE CARE. THE PT IS IN GOOD CONDITION AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF281 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability FREEZOR MAX CARDIAC CRYOABLATION CATHETER| FLEXCATH SHEATH