BEUDAMED
    FDA Adverse Event Summary report: N

    STENT, URETERAL, PERCUFLEX PLUS

    MDR report key: 2150364 · Received June 21, 2011

    Report

    Report Number
    2150364
    Date Received
    June 21, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE POSITIONER OF THE URETERAL STENT WAS LEFT IN THE PT AFTER THE PROCEDURE WAS COMPLETE. THE ISSUE WAS PRIMARILY A PHYSICIAN ONE. HOWEVER, IN SOME CASES THE PHYSICIAN STATES THAT THE POSITIONER IS NOT LONG ENOUGH TO LEAVE SOME OF THE POSITIONER OUTSIDE THE BODY TO HOLD ON TO. IN THIS CASE, THE POSITIONER WAS FLUSH WITH THE MEATUS AND THEN LEFT INSIDE THE PT. THERE IS ONLY A SMALL RING THAT IS RADIOPAQUE AND WE FEEL A LARGER RING WOULD HELP IDENTIFY IF THE ITEM IS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STENT, URETERAL, PERCUFLEX PLUS PERCUFLEX PLUS URETERAL STENT FAD BOSTON SCIENTIFIC M006175263 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR