BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2883280 · Received December 21, 2012

    Report

    Report Number
    3002648230-2012-00137
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. NEITHER BIN FILES NOR FAILURE FILES SHOW ANY SYSTEM NOTICE FOR THE DATE OF EVENT. BIN FILES SHOW THAT AT LEAST (B)(4) INJECTIONS WERE PERFORMED WITH THE CATHETER. 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

    CRYOABLATION PROCEDURE PERFORMED (B)(6) 2012. SINCE PROCEDURE, PATIENT HAS HAD A PERSISTENT COUGH AND HEMOPTYSIS. PATIENT DOES NOT HAVE A PHRENIC NERVE PALSY AND CT SHOWS NO PULMONARY VEIN STENOSIS OR ANY OTHER FINDINGS.

    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 00048 YR Other