BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 3201634 · Received July 2, 2013

    Report

    Report Number
    3002648230-2013-00102
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    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 RETURNED DEVICE (CATHETER 2AF284 / 77525-80) WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. FAILURE FILES CONFIRM SYSTEM NOTICE MESSAGE 50005 "LEAK DETECTION" FOR THE DATE OF EVENT. BIN FILES DO NOT SHOW ANY SYSTEM NOTICES OR ISSUES WITH THE PERFORMED INJECTIONS. BIN FILES ALSO SHOW AT LEAST (B)(4) INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 77525-80 AND AT LEAST (B)(4) INJECTIONS WERE PERFORMED WITH CATHETER 2AF284 / 77525-07 (NOT RETURNED). VISUAL INSPECTION OF CATHETER 2AF284 / 77525-80 SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR (B)(4) INJECTIONS. CATHETER 2AF284 / 77525-80 PASSED THE INSPECTION AS PER SPECIFICATION: THE CATHETER PASSED THE PERFORMANCE TEST; ELECTRICAL INTEGRITY AND IMPEDANCE WERE 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

    RIGHT PHRENIC NERVE INJURY WAS OBSERVED: LOSS OF PHRENIC PACING AFTER 52 SECONDS OF ABLATION IN RSPV (FIRST ABLATION AT THIS SITE). THE PHYSICIAN OBSERVED LOSS OF TWO BEATS OF PHRENIC PACING AND IMMEDIATELY DISCONTINUED ABLATION. LOWEST TEMPERATURE WAS -49 DEGREES CELSIUS. PHRENIC NERVE FUNCTION DID NOT RETURN BEFORE THE END OF THE PROCEDURE AND HAD NOT RETURNED ON FOLLOW UP INSPIRATION X-RAY ON (B)(6) 2013. THE PHYSICIAN REPORTED THAT THE PATIENT WAS ENTIRELY ASYMPTOMATIC AT THE TIME OF DISCHARGE ON (B)(6) 2013. IT WAS ALSO REPORTED THAT SYSTEM NOTICE MESSAGE 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION) WAS TRIGGERED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301648 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 77525

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Other