BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE

    MDR report key: 4891450 · Received June 26, 2015

    Report

    Report Number
    4891450
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 26, 2015
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STONE RETRIEVAL BASKET BECAME LODGED AROUND LARGE URETERAL STONE DURING A CYSTOSCOPY LASER LITHOTRIPSY. STONE BASKET WAS DISASSEMBLED AND REASSEMBLED WHILE INSIDE URETER/BLADDER AND THE DISTAL MOST PIECE OF THE RETRIEVAL DEVICE BROKE OFF AND REMAINS RETAINED IN THE PATIENT EITHER IN THE URETER OR BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416191 SEGURA HEMISPHERE DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC * 17281905

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR