BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBER

    MDR report key: 40557 · Received September 27, 1996

    Report

    Report Number
    2183819-1996-00028
    Event Type
    Injury
    Date Received
    September 27, 1996
    Date of Event
    August 26, 1996
    Report Date
    September 27, 1996
    Manufacturer
    SCIMED LIFE SYSTEMS, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA PROCEDURE, THE GUIDING CATHETER KINKED. AS THE GUIDING CATHETER WAS BEING REMOVED, IT MOVED TO THE LEFT MAIN CORONARY ARTERY AND A DISSECTION OCCURRED. ANOTHER MFR'S BALLOON CATHETER WAS USED TO REPAIR THE DISSECTION. THE PHYSICIAN DETERMINED THAT SURGERY WOULD NOT BE PERFORMED. PT STATUS IS LISTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBER CORONARY GUIDEING CATHETER DQX SCIMED LIFE SYSTEMS, INC. 8FC/FL4 D69098

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention