BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAG PRECURSOR

    MDR report key: 1290997 · Received January 16, 2009

    Report

    Report Number
    3005099803-2009-00209
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    December 17, 2008
    Report Date
    December 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 3005099803-2009-00210. IT WAS REPORTED THAT DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, RESISTANCE WAS ENCOUNTERED AND A GUIDE WIRE COATING DETACHMENT OCCURRED. THE "SEVERLY" STENOSED LESION WAS LOCATED IN AN UNSPECIFIED BILE DUCT. A 0.025 JAG PRECURSOR GUIDE WIRE WAS ADVANCED TO THE LESION. HOWEVER, RESISTANCE WAS ENCOUNTERED. IN EFFORTS TO CROSS THE LESION, THE PHYSICIAN ATTEMPTED TO ADVANCE AND RETRACT THE GUIDE WIRE SEVERAL TIMES AFTER WHICH TIME IT WAS NOTED THAT THE DISTAL COATING ON THE GUIDE WIRE HAD DETACHED AND REMAINED INSIDE THE PT. THE DETACHED COATING WAS REMOVED UTILIZING A FORCEPS. A SECOND 0.025 JAG PRECURSOR GUIDE WIRE WAS ADVANCED, HOWEVER, THE SAME EVENT OCCURRED. THE DEVICE WAS REMOVED AND AN THIRD, UNSPECIFIED GUIDE WIRE WAS ADVANCED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDE WIRE EZB BOSTON SCIENTIFIC M0055656011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention