BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2010562 · Received March 1, 2011

    Report

    Report Number
    3002648230-2011-00009
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE ARCTIC FRONT CATHETER. BOTH PHRENIC NERVE PACING AND DIAPHRAGMATIC PALPATION WERE PRACTICED WITH BOTH RIGHT SIDED VEINS. THE PT EXPERIENCED PHRENIC NERVE PALSY 68 SECONDS INTO THE FIRST TREATMENT OF THE RIGHT SUPERIOR PULMONARY VEIN. THE ENERGY APPLICATION WAS IMMEDIATELY TERMINATED. PARTIAL RECOVERY OF DIAPHRAGMATIC MOVEMENT WAS NOTED AT THE COMPLETION OF THE PROCEDURE. THE PT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING MORNING AND WAS SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF232 06812

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Disability