BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PUNCH

    MDR report key: 899887 · Received July 23, 2007

    Report

    Report Number
    899887
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 18, 2007
    Report Date
    July 23, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE. WHEN THE DISPOSABLE AORTIC PUNCH WAS POSITIONED AND FIRED TO MAKE HOLE IN AORTA FOR ATTACHMENT OF THE GRAFT, THE DEVICE MISFIRED. INSTEAD OF MAKING A HOLE, IT MADE A TEAR. THE DEVICE WAS POSITIONED IN THE SAME PLACE, RE-FIRED, AND AN ADEQUATE HOLE WAS MADE. THE PHYSICIAN REPORTED THAT SINCE THE ORIGINAL MANUFACTURER OF THIS DEVICE WAS BOUGHT OUT, THE PUNCHES MADE BY THIS DEVICE DO NOT CUT AS CLEANLY AS THEY SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PUNCH AORTIC PUNCH DWS TELEFLEX MEDICAL * 70730-1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR