BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 836723 · Received April 4, 2007

    Report

    Report Number
    MW1042508
    Event Type
    Other
    Date Received
    April 4, 2007
    Date of Event
    March 16, 2007
    Report Date
    April 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ECRP PROCEDURE, TRAPEZOID BASKET WIRE BROKE OFF INSIDE PT, LEAVING A SMALL PIECE OF THE BASKET INSIDE THE PT. THE PIECE COULD NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TRAPEZOID RX LQC BOSTON SCIENTIFIC M00510870 9389337

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other