BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAG PRECURSOR

    MDR report key: 1302564 · Received January 29, 2009

    Report

    Report Number
    3005099803-2009-00334
    Event Type
    Malfunction
    Date Received
    January 29, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 6, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOSCOPY (ERCP) PROCEDURE, A GUIDE WIRE COATING DETACHMENT OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED BILE DUCT. UPON ATTEMPTING TO ADVANCE THE 0.035 JAG PRECURSOR GUIDE WIRE INTO THE PAPILLA, THE COATING ON THE DISTAL TIP OF THE GUIDE WIRE FELL OFF AND REMAINED INSIDE THE PATIENT'S DUODENUM. NO ATTEMPT WAS MADE TO RETRIEVE THE DETACHED COATING AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S STATUS IS REPORTED AS "STABLE". IT IS THE PHYSICIAN'S OPINION THAT THE DETACHED COATING WILL PASS BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAG PRECURSOR MDM-GUIDEWIRE EZB BOSTON SCIENTIFIC M0055658011 12099035

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR