BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 12019 · Received January 26, 1994

    Report

    Report Number
    12019
    Event Type
    Injury
    Date Received
    January 26, 1994
    Date of Event
    January 16, 1994
    Report Date
    January 24, 1994
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ANGIOPLASTY THE DISTAL END OF THE "C" WIRE REMAINED IN THE ARTERY (APPROX 15-20 CM). ATTEMPTS WERE MADE TO REMOVE, OR POSSIBLY SECURE BY USING A STENT, HOWEVER, THESE ATTEMPTS WERE NOT SUCCESSFUL. IT WAS DECIDED AT THAT TIME TO END THE PROCEDURE WHILE THAT PT REMAINED IN STABLE CONDITION. THE WIRE WAS REMOVED SURGICALLY ON 1/18. THE PT REMAINS IN CVICU AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE GUIDE WIRE, 310 CM MCW HEART TECHNOLOGY, INC. W-23024

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention