BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 4210629 · Received October 29, 2014

    Report

    Report Number
    3002648230-2014-00186
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. BIN FILES WERE REVIEWED AND DO NOT SHOW SYSTEM NOTICES OR ISSUES FOR THE DATE OF EVENT. BIN FILES SHOW THAT AT LEAST 9 INJECTIONS WERE PERFORMED WITH THE CATHETER.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION; IT WAS DISCARDED AFTER THE PROCEDURE. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION OF A PHRENIC NERVE INJURY THAT OCCURRED DURING A CRYOABLATION PROCEDURE. USER LOST PHRENIC NERVE CAPTURE WHILE ABLATING IN THE RIGHT SUPERIOR PULMONARY VEIN. THE PROCEDURE WAS COMPLETED WITH RADIOFREQUENCY (RF) ABLATION RATHER THAN CRYOABLATION. AT THE END OF THE PROCEDURE, PHRENIC NERVE CAPTURE HAD NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691621 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284 63721

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other