BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRA JAG

    MDR report key: 633412 · Received September 7, 2005

    Report

    Report Number
    6000123-2005-00067
    Event Type
    Injury
    Date Received
    September 7, 2005
    Date of Event
    July 14, 2005
    Report Date
    July 20, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ERCP PROCEDURE, THE GUIDE WIRE WAS CAUGHT IN THE STENT AND PHYSICIAN WAS UNABLE TO PLACE THE STENT. PTFE COATING PEELED OFF THE GUIDE WIRE AS A RESULT OF THE DIFFICULTY DURING INSERTION. THE STENT WAS EVENTUALLY PLACED PERCUTANEOUSLY IN THE COMMON BILE DUCT.

    Description of Event or Problem · 1

    A HYDRA JAG WAS USED FOR A THERAPEUTIC ERCP. DURING THE PROCEDURE, THE PTFE COATING PEELED OFF. AS A RESULT, THE PT WAS SENT TO SURGERY TO HAVE A PERCUTANEOUS STENT PLACED. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRA JAG JAGWIRE KOG BOSTON SCIENTIFIC * 7266768

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention