BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2760415 · Received September 26, 2012

    Report

    Report Number
    3002648230-2012-00078
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE CATHETER PASSED THE INSPECTION AS PER SPECIFICATION. VISUAL INSPECTION SHOWED THE CATHETER WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 10 INJECTIONS. THE CATHETER PASSED THE PERFORMANCE TEST AND ELECTRICAL INTEGRITY AS PER SPECIFICATION; IMPEDANCE WAS ALSO WITHIN SPECIFICATION. DISSECTION / PRESSURE TESTS DID NOT SHOW ANY LEAKS OR TRACES OF LIQUID/BLOOD INSIDE THE CATHETER. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    DURING CRYOABLATION OF RSPV, THE PATIENT EXPERIENCED PHRENIC NERVE PALSY 100 SEC INTO FREEZE. AS PER PHYSICIAN, PHRENIC NERVE PACING WAS BEING OBSERVED BY PALPATION OF ABDOMEN. CRYO WAS TERMINATED IMMEDIATELY UPON PHYSICIAN'S ORDER. TEMPERATURE OF FREEZE AT THIS TIME (09:43) WAS -57 DEGREES. CASE DISCONTINUED AT 10:25 AFTER ALL VEINS WERE CHECKED FOR ISOLATION, PHRENIC NERVE CONTRACTION HAD NOT RETURNED AT CASE END. THE PATIENT WAS SENT HOME AFTER THE CRYOABLATION PROCEDURE, BUT RETURNED TO HOSPITAL EXPERIENCING COMPLICATION OF RESPIRATORY DISTRESS AND ATRIAL FIBRILLATION.

    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 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other