BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 1336135 · Received December 17, 2008

    Report

    Report Number
    3005099803-2008-07187
    Event Type
    Malfunction
    Date Received
    December 17, 2008
    Date of Event
    November 14, 2008
    Report Date
    November 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    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 #: 3005099803-2008-07186. IT WAS REPORTED THAT DURING AN ENDOSCOPIC BILIARY STENTING PROCEDURE THE TIPS OF TWO JAG PRECURSOR GUIDE WIRES DETACHED. THE PHYSICIAN INSERTED ONE JAG PRECURSOR WIRE INTO THE CONTRAST MEDIA TUBE, BUT RESISTANCE WAS FELT AND "IT TOOK A LONG TIME" FOR THE GUIDE WIRE TO PASS THROUGH THE TUBE. PRIOR TO ATTEMPTING TO DEPLOY A FLEXIMA BILIARY STENT, IT WAS NOTED THAT THE TIP OF THE GUIDE WIRE WAS MISSING. THE GUIDE WIRE AND FLEXIMA BILIARY STENT SYSTEM WERE REMOVED FROM THE PT AND ANOTHER WAS INSERTED. THE FLEXIMA BILIARY STENT WAS SUCCESSFULLY DEPLOYED IN THE INFERIOR DIVISION OF THE BILIARY DUCT, BUT THE TIP OF THE SECOND WIRE WAS ALSO FOUND TO BE DETACHED. THERE WERE NO PT COMPLICATIONS AND THE PT WAS REPORTED TO BE GOOD. NO ATTEMPTS WERE MADE TO RETRIEVE THE DETACHED GUIDE WIRE TIPS AND A CONTRAST STUDY FIVE DAYS POST PROCEDURE SHOWED NO EVIDENCE OF THE GUIDE WIRE TIPS REMAINING IN THE PT. THE PHYSICIAN FELT IT WAS LIKELY THAT THE GUIDE WIRE TIPS WERE "EVACUATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055660011 9557850

    Patients

    Seq Age Sex Outcome Treatment
    1