BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT VASCULAR

    MDR report key: 2577027 · Received December 4, 2009

    Report

    Report Number
    2577027
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 1, 2009
    Manufacturer
    ABBOTT VASCULAR INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER STENT WAS DEPLOYED, THE TIP OF THE GRAND SLAM 300CM WIRE HAD BROKEN OFF AND WAS LOGGED IN THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT VASCULAR ASAHI GRAND SLAM GUIDE WIRE DQX ABBOTT VASCULAR INC AG141302 071217A441

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization