BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1170144 · Received September 11, 2008

    Report

    Report Number
    3005099803-2008-04481
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE GUIDE WIRE TIP APPEARED PEELED. A JAG PRECURSOR HAD BEEN USED IN THE PROCEDURE WITH A NON-BSC SCOPE AND NON-BSC CANNULA. AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE COATING ON THE TIP OF THE GUIDE WIRE APPEARED "PEELED". IT IS UNK IF COATING FRAGMENTS ARE INSIDE THE PATIENT. THE PHYSICIAN EXPECTS ANY COATING FRAGMENTS THAT MAY BE INSIDE THE PATIENT WILL BE "ELIMINATED NATURALLY BY ITSELF LATER ON." THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055658011 8530188

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS JF-230| COOK