BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1222842 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06108
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, THE GUIDE WIRE COATING WAS ROUGH. THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE,THE COATING ON THE JAGWIRE PRECURSOR 035/450 HAD BECOME PARTIALLY BUNCHED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055658011 11811818

    Patients

    Seq Age Sex Outcome Treatment
    1