BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE GUIDE WIRE

    MDR report key: 80962 · Received March 27, 1997

    Report

    Report Number
    2024168-1997-00046
    Event Type
    Malfunction
    Date Received
    March 27, 1997
    Report Date
    March 27, 1997
    Manufacturer
    ACS/DVI
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF A STENT DELIVERY SYSTEM OVER THE GUIDE WIRE RESISTANCE WAS MET. AT THAT TIME THE STENT DELIVERY SYSTEM AND THE GUIDE WIRE WERE REMOVED TOGETHER. UPON TESTING OUTSIDE THE BODY, ATTEMPTS TO REMOVE THE WIRE FROM THE STENT DELIVERY SYSTEM RESULTED IN GUIDE WIRE TIP SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE GUIDE WIRE GUIDE WIRE DQX ACS/DVI N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN