BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 2487861 · Received March 7, 2012

    Report

    Report Number
    MW5024578
    Event Type
    Injury
    Date Received
    March 7, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ABBOTT LABS
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT MULTI-VESSEL PERCUTANEOUS CORONARY INTERVENTION WITH STENTING OF RIGHT CORONARY ARTERY AND LEFT ANTERIOR DESCENDING ARTERY. IT WAS REPORTED THAT DURING THE PROCEDURE, A GUIDEWIRE FRACTURED IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING THE PROCEDURE, IT WAS REPORTED THE PT WAS EXPERIENCING CHEST PAIN AND THE PROCEDURE WAS CONVERTED TO A CORONARY ARTERY BYPASS GRAFTING X3 (THREE) WITH RETRIEVAL OF THE FRACTURED WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE BALANCE MIDDLE WEIGHT GUIDEWIRE 0.014"/ 190CM DQX ABBOTT LABS 1001780-HC 1082372

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention