BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR

    MDR report key: 16386 · Received July 8, 1994

    Report

    Report Number
    16386
    Event Type
    Injury
    Date Received
    July 8, 1994
    Date of Event
    May 12, 1994
    Report Date
    July 5, 1994
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN CATH LAB FOR ABLATION OF RCA. ON REMOVAL OF THE ADVANCER/CATHETER AND GUIDE WIRE, THE GUIDE WIRE SPRING TIP WAS NOTED TO BE UNCOILED. TWO PIECES OF WIRE WERE IMBEDDED IN THE ARTERY AND COULD NOT BE REMOVED. THE PT WAS TAKEN TO THE OR FOR EMERGENCY TWO VESSEL CABG AND REMOVAL OF FOREIGN BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTABLATOR GUIDE WIRE, TYPE C MCX HEART TECHNOLOGY, INC. RGA051294-1C

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R