BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTOLBLATOR/ROTABLATOR/FLOPPY WIRE

    MDR report key: 59776 · Received January 3, 1997

    Report

    Report Number
    59776
    Event Type
    Malfunction
    Date Received
    January 3, 1997
    Date of Event
    December 4, 1996
    Report Date
    December 16, 1996
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POST ROTABLATION WHEN REMOVING WIRE SEVERED AND WAS FOUND IN A SMALL SEPTAL BRANCH, UNSUCCESSFUL ATTEMPT TO RETRIEVE. RETAINED IN SMALL SEPTAL PERFERATOR VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTOLBLATOR/ROTABLATOR/FLOPPY WIRE * DQX HEART TECHNOLOGY, INC. * 62169

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other