BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUIBREGTSE GUIDING CATHETER

    MDR report key: 1581013 · Received January 14, 2010

    Report

    Report Number
    3001845648-2010-00001
    Event Type
    Death
    Date Received
    January 14, 2010
    Date of Event
    August 3, 2009
    Report Date
    December 14, 2009
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION; THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE LOT NUMBER OF THE DEVICE IS UNKNOWN; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF PRODUCT FROM THE SAME LOT NUMBER IS IN STOCK. PRIOR TO DISTRIBUTION, HGC-6 DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND DIMENSIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED AS THE DEVICE LOT NUMBER IS UNK. A 2 YEAR COMPLAINT HISTORY HAS BEEN REVIEWED FOR THIS PRODUCT FAMILY AND THE COMPLAINT RATE FOR THIS PRODUCT IS LOW. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. HOWEVER, COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME AS ONLY LIMITED INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE CATHETER APPEARED TO KINK DURING USE. PT DIED. NO FURTHER INFO HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUIBREGTSE GUIDING CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death