BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLE WEIGHT

    MDR report key: 2953990 · Received January 30, 2013

    Report

    Report Number
    2953990
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A STENT PROCEDURE, 1MM OF THE GUIDE WIRE TIP BROKE OFF. THE PHYSICIAN SECURE THE WIRE TIP BY USING A STENT TO 'JAIL' THE WIRE TIP INTO THE VESSEL WALL. THE PATIENT'S CORONARY ARTERIES ARE NOT TORTUOUS. THE TIP OF THE WIRE GOT CAUGHT IN THE MIDDLE OF THE STENT ON A STRUT. NO INFORMATION REGARDING THE STENT IS AVAILABLE. NO PATIENT HARM: NO ADDITIONAL PROCEDURES/TREATMENT REQUIRED RELATED TO THIS EVENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?STENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39810 HI-TORQUE BALANCE MIDDLE WEIGHT WIRE, GUIDE, CATHETER DQX ABBOTT VASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR