BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DLP AORTIC ROOT CANNULAE

    MDR report key: 4154853 · Received September 24, 2014

    Report

    Report Number
    4154853
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC DLP REF 10012, 12 GA OTHERWISE KNOWN AS COLD NEEDLE, LOT #2014031020 WAS USED IN THIS CASE, AORTIC VALVE REPLACEMENT/CORONARY ARTERY BYPASS GRAFTING (AVR/CABG). THE HUB OF THE NEEDLE COULDN'T BE RELEASED FROM THE OBTURATOR, INSTEAD IT CREATED A CRACK AND BROKE BELOW THE LEVEL OF THE HUB CREATING A HOLE IN THE AORTA. NOTE: IN READING THE OP REPORT, NO MENTION WAS MADE OF ANY ILL EFFECTS TO THE PATIENT DURING OR AFTER THE SURGERY. THE ITEM WAS SEQUESTERED AND GIVEN TO RISK. THE REMAINING COLD NEEDLES WITH THE SAME LOT NUMBER WERE PULLED AND GIVEN TO SUPPLY CHAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593552 DLP AORTIC ROOT CANNULAE AORTIC ROOT CANNULA DWF MEDTRONIC * 2014031020

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR