BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2023567 · Received March 16, 2011

    Report

    Report Number
    3002648230-2011-00013
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER MARKETED IN THE UNITED STATES. 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 IN THE UNITED KINGDOM USING THE ARCTIC FRONT CATHETER. A PHRENIC NERVE PALSY OCCURRED 60 SECONDS INTO ONE OF THE FIRST TREATMENTS OF THE RSPV, AND THE CRYOABLATION WAS STOPPED. ADDITIONAL ABLATIONS WERE DONE TO THE LEFT SIDED VEINS. THE NERVE FUNCTION HAD NOT RECOVERED AFTER 30 MINUTES AND THE PROCEDURE WAS STOPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability