BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR GUIDE WIRE WITH WIRECLIP TORQUER

    MDR report key: 46127 · Received July 31, 1996

    Report

    Report Number
    46127
    Event Type
    Malfunction
    Date Received
    July 31, 1996
    Date of Event
    March 19, 1996
    Report Date
    March 20, 1996
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDE WIRE WAS ADVANCED ACROSS THE STENOSIS IN THE LAD ARTERY AND WENT INTO THE SEPTAL. THE WIRE THEN SEEMED TO GET STUCK IN THE SEPTAL, AND AS IT WAS PULLED BACK TO ADVANCE INTO THE MAIN LAD ARTERY, THE DISTAL TIP (APPROX 5MM) BROKE OFF AND REMAINED IN THE SEPTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE WITH WIRECLIP TORQUER "C SOFT" DQX HEART TECHNOLOGY, INC. * W-59415

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other