BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREYHOUND

    MDR report key: 16875444 · Received May 5, 2023

    Report

    Report Number
    16875444
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 26, 2023
    Report Date
    May 2, 2023
    Manufacturer
    VITALITEC INT'L., INC.
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    VITALITEC GREYHOUND ADJUSTABLE SPRING CLIP, PLACED ON THE RIGHT INTERNAL MAMMARY ARTERY, BROKE AND CAME LOOSE DURING HEART BYPASS SURGERY. THE PATIENT WAS PUT AT RISK, GETTING A RHYTHM BACK UNEXPECTEDLY IN THE MIDDLE OF SURGERY CAUSING THE SURGEON TO STOP WORKING, PUT THE PATIENT AT RISK TO GIVE MORE CARDIOPLEGIA, AND PUT HIS HAND IN THE CHEST BEHIND THE HEART WHERE SOME WORK HAD ALREADY BEEN COMPLETED. PROCEDURE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692350 GREYHOUND CLAMP, VASCULAR DXC VITALITEC INT'L., INC. N10157

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Male