BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2882268 · Received December 20, 2012

    Report

    Report Number
    3002648230-2012-00136
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    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. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE FIRST CRYOABLATION OF THE RIGHT MIDDLE PULMONARY VEIN, PHRENIC NERVE PACING CAPTURE WAS LOST AND THE TREATMENT WAS IMMEDIATELY STOPPED AT 45 SECONDS. A TEMPERATURE OF -46C HAD BEEN REACHED DURING THIS APPLICATION. RIGHT PHRENIC NERVE PACING CAPTURE WAS NOT AGAIN ACHIEVED THROUGH THE COMPLETION OF THE PROCEDURE. FOLLOW-UP ON (B)(6) 2012 INDICATED THAT THE RIGHT PHRENIC NERVE IMPAIRMENT HAD STILL NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF234 30771

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Other