BEUDAMED
    FDA Adverse Event Death Summary report: N

    NBCA LIQUID EMBOLIC SYSTEM 2

    MDR report key: 1060785 · Received June 12, 2008

    Report

    Report Number
    1058196-2008-00156
    Event Type
    Death
    Date Received
    June 12, 2008
    Date of Event
    November 20, 2007
    Report Date
    June 10, 2008
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    MFE
    PMA / PMN Number
    P990040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING AND REVIEWING THE MEDWATCH REPORT FROM THE HOSP, TWO DIFFERENT LOT NUMBERS WERE USED. THIS IS ONE OF TWO PRODUCTS USED ON THE SAME PT. MFR REPORT # 1058196-2008-00153. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    CORDIS RECEIVED INFO THAT A PHYSICIAN INDICATED THAT WHEN PERFORMING AN AUTOPSY ON A BABY WHERE TRUFILL NBCA GLUE WAS USED TO EMBOLIZE SOME FEEDER VESSELS TO A HEPATIC AVM, THE GLUE CAUSED FATAL PES AND PULMONARY HTN AND THE PT EXPIRED. CORDIS CONTACTED THE RISK MGR OF THIS HOSP AND WAS INFORMED THEY DID NOT HAVE ANY KNOWLEDGE OF THIS EVENT. FOLLOWING MEETING WITH THEIR COMMITTEES, THEY WILL BE SENDING THE FDA A VOLUNTARY MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCA LIQUID EMBOLIC SYSTEM 2 CNV NBCA (MFE) MFE CORDIS NEUROVASCULAR, INC. NA 13242881

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY Death