BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTCA WIRE

    MDR report key: 23957 · Received July 6, 1995

    Report

    Report Number
    23957
    Event Type
    Injury
    Date Received
    July 6, 1995
    Date of Event
    February 20, 1995
    Report Date
    February 28, 1995
    Manufacturer
    CORDIS
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING PTCA PROCEDURE, MD ATTEMPTED TO ADVANCE THE GTO DEVICE INTO THE RCA OVER LUCEE WIRE WHEN TIP CAME APART FROM WIRE. MD ATTEMPTED TO REMOVE WIRE TIP UNSUCCESSFULLY RESULTING IN DISSECTION OF THE PROXIMAL RIGHT CORONARY ARTERY. PT THEREFORE REQUIRED CORONARY BYPASS GRAFT AND REMOVAL OF FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA WIRE PTCA WIRE DQX CORDIS H1094043

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention