BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1202852 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05320
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE JAGWIRE PRECURSOR WIRE FRAGMENTED. THE PHYSICIAN WAS USING THE JAGWIRE PRECURSOR WITH A SPHINCTEROTOME AND NOTED FRAGMENTS FROM THE TIP OF THE WIRE WERE LOOSE AND DROPPED INTO THE DUODENUM. THE PHYSICIAN REPORTED THAT NO RESISTANCE WAS FELT DURING THE PROCEDURE. THE CATHETER AND GUIDE WIRE WERE REMOVED AND ANOTHER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT COMPLICATIONS. NO ACTION WAS TAKEN TO REMOVE THE WIRE FRAGMENTS, AS THE PHYSICIAN FELT THEY WOULD PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE MDM - GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055658011 9585762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other