BEUDAMED
    FDA Adverse Event Summary report: N

    ROTABLATOR TYPE C GUIDE WIRE .009

    MDR report key: 28240 · Received July 1, 1995

    Report

    Report Number
    28240
    Date Received
    July 1, 1995
    Report Date
    June 30, 1995
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WIRE BROKE INSIDE PT'S LEFT CORONARY ARTERY WHILE WITHDRAWING WIRE AFTER PROCEDURE. PT REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR TYPE C GUIDE WIRE .009 GUIDE WIRE DQX HEART TECHNOLOGY, INC. W-47256

    Patients

    Seq Age Sex Outcome Treatment
    1 *