BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASIVE

    MDR report key: 25549 · Received July 28, 1995

    Report

    Report Number
    25549
    Event Type
    Injury
    Date Received
    July 28, 1995
    Date of Event
    April 10, 1995
    Report Date
    April 25, 1995
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FAD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING AN ESWL AT AN OUTPATIENT FACILITY THE SURGEON ATTEMPTED TO REMOVE THE STENT. DURING THE PROCEDURE, THE STENT BROKE OFF INTO TWO PARTS LEAVING ABOUT 1/3 OF THE PROXIMAL PART OF THE STENT IN THE RIGHT URETER. AN IVP DONE ON 4/10/95 SHOWED A PARTIAL OBSTRUCTION OF THE RIGHT SIDE. THE PT ENTERED THIS FACILITY FOR REMOVAL OF THE RETAINED URETERAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE Implant URETERAL STENT FAD BOSTON SCIENTIFIC CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R