BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONVEY

    MDR report key: 6060019 · Received October 27, 2016

    Report

    Report Number
    0000000-2016-00002
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 27, 2016
    Manufacturer
    PENDRACARE INTERNATIONAL B.V.
    Product Code
    DQY
    UDI-DI
    08714729849865
    PMA / PMN Number
    120585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISPOSED.

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE, WHILE REMOVING THE BALLOON CATHETER, THE GUIDE WIRE AND GUIDING CATHETER A DISSECTION OCCURRED IN THE CORONARY ARTERY. THERE WAS NO FLOW ANYMORE. THE PATIENT COLLAPSED AND NEEDED TO BE REANIMATED. THE PATIENT WAS TRANSFERRED URGENTLY TO A SURGICAL CENTER FOR URGENT SURGERY. THE PATIENT FINALLY DIED OF NEUROLOGICAL DAMAGE AFTER REANIMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVEY GUIDING CATHETER, PRODUCT CODE: DQY DQY PENDRACARE INTERNATIONAL B.V. H749392647140 1607-0049 08714729849865

    Patients

    Seq Age Sex Outcome Treatment
    1 Death