BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2970063 · Received February 20, 2013

    Report

    Report Number
    3002648230-2013-00028
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. BIN FILES WERE REVIEWED AND DO NOT SHOW ISSUES OR SYSTEM NOTICE MESSAGES. BIN FILES SHOW THAT AT LEAST 12 INJECTIONS WERE PERFORMED WITH THE CATHETER. THERE WAS NO INDICATION OF PRODUCT MALFUNCTION. THIS REPORT WILL BE RECORDED AND TRENDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER THE COMPLETION OF A CRYOABLATION PROCEDURE, THE PATIENT HAD A PERICADIAL EFFUSION AND APPROXIMATELY 500CC WAS DRAINED FROM THE PERICARDIAL SAC. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE DAY FOLLOWING THE PROCEDURE, AS PER NORMAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73844 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF234

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention