BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIGHTY

    MDR report key: 34567 · Received July 11, 1996

    Report

    Report Number
    34567
    Event Type
    Injury
    Date Received
    July 11, 1996
    Date of Event
    June 28, 1996
    Report Date
    July 11, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CORONARY ANGIOPLASTY POST STENT DILATION WAS PERFORMED AND BALLOON RUPTURED. THE BALLOON COULD NOT BE REMOVED FROM THE PT EASILY AND PART OF THE BALLOON STAYED IN THE PT'S RIGHT CORONARY ARTERY. ON 6/29/96, PT WAS TAKEN TO SURGERY. CORONARY ARTERY BYPASS GRAFT X2 WITH REMOVAL OF BALLOON FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIGHTY PTCA BALLOON DILATION CATHETER LOX SCIMED LIFE SYSTEMS, INC. 272126

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R