BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1151313 · Received September 4, 2008

    Report

    Report Number
    3005099803-2008-04332
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 3, 2008
    Report Date
    August 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. A JAG PRECURSOR 035/450 GUIDE WIRE HAD BEEN SELECTED FOR USE IN AN UNSPECIFIED PANCREATIC LOCATION IN THE "BILIARY WAY" . DURING INTRODUCTION, THE TIP OF THE GUIDE WIRE DETACHED FROM THE CORE WIRE AND SEPARATED INTO 2 FRAGMENTS. ONE OF THE TIP FRAGMENTS STAYED IN THE "TERMINAL PART OF THE BILIARY WAY" AND THE SECOND STAYING IN THE CANAL OF WIRSUNG. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO REMOVE THE DEVICE FRAGMENTS BY UNSPECIFIED MEANS. THE PROCEDURE WAS CONSIDERED TO BE COMPLETED WITH THIS DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE EZB BOSTON SCIENTIFIC M0055658011 8439525

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R