BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALANCED MIDDLEWEIGHT

    MDR report key: 2250862 · Received September 8, 2011

    Report

    Report Number
    2250862
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 8, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    DURING STENT PLACEMENT, TWO DIFFERENT GUIDEWIRE TIPS BROKE OFF INSIDE OF THE PATIENT'S BODY, IN THE CORONARY ARTERY. THE WIRE TIPS WERE NOT RETRIEVABLE AND WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALANCED MIDDLEWEIGHT GUIDEWIRE DQX ABBOTT VASCULAR .014X190 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR NO OTHER THERAPIES| NONE KNOWN