BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRA JAG GUIDEWIRE

    MDR report key: 1172147 · Received September 18, 2008

    Report

    Report Number
    3005099803-2008-04680
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FDE
    PMA / PMN Number
    K942677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #3005099803-2008-04682. IT WAS REPORTED THAT DURING A GASTRO-INTESTINAL (GI) STENTING PROCEDURE, ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE DUODENUM. UPON ADVANCING THE WALLFLEX ENTERAL DUODENAL 22MMX 9MM STENT DELIVERY SYSTEM (SDS) OVER THE 0.035 HYDRA-JAG GUIDE WIRE, THE SDS BECAME STUCK ON THE GUIDE WIRE MAKING IT IMPOSSIBLE TO ADVANCE OR WITHDRAW THE DEVICE. THE SDS AND GUIDE WIRE WERE REMOVED FROM THE PATIENT AS A UNIT. ANOTHER OF THE SAME OF EACH DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRA JAG GUIDEWIRE FDE BOSTON SCIENTIFIC M00556041 11360653

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR