BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CATHETER

    MDR report key: 18973 · Received November 14, 1994

    Report

    Report Number
    18973
    Event Type
    Injury
    Date Received
    November 14, 1994
    Date of Event
    October 26, 1994
    Report Date
    November 10, 1994
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING ANGIOPLASTY "WIRE BROKE" CAUSING HARM TO RIGHT CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC CATHETER CARDIAC CATHETER LOX HEART TECHNOLOGY, INC. 94158

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening