BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOGARD EMBOLI PROTECTION CANNULA

    MDR report key: 5359854 · Received January 12, 2016

    Report

    Report Number
    3011427673-2016-00001
    Event Type
    Injury
    Date Received
    January 12, 2016
    Date of Event
    August 9, 2015
    Report Date
    August 11, 2015
    Manufacturer
    CARDIOGARD MEDICAL LTD.
    Product Code
    NCP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE DEVICE'S MAIN TUBE WAS FOUND TO BE KINKED WHEN THE NURSE OPENED THE PACKAGE. IT WASN'T USED IN THE SURGERY, A DIFFERENT CANNULA WAS USED INSTEAD. THE DEVICE WAS SENT BACK TO THE MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18508 CARDIOGARD EMBOLI PROTECTION CANNULA AORTIC CANNULA NCP CARDIOGARD MEDICAL LTD. PRT20140927

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention