BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEMINI 3 WIRE BASKET

    MDR report key: 2022637 · Received February 9, 2011

    Report

    Report Number
    2022637
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE WIRES WERE BROKEN AT THE BASE OF THE BASKET AND REFUSED TO CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEMINI 3 WIRE BASKET 3 WIRE BASKET LQR BOSTON SCIENTIFIC 330-306 13666347

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR