BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNX

    MDR report key: 2151632 · Received July 5, 2011

    Report

    Report Number
    2151632
    Event Type
    Death
    Date Received
    July 5, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 5, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE PATIENT WAS IN THE POST PROCEDURE AREA SHE BECAME HYPOTENSIVE AND UNRESPONSIVE. A CODE WAS SUBSEQUENTLY CALLED AND THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA). WHEN THE PATIENT REGAINED A PULSE SHE WAS TRANSPORTED TO THE CATH LAB WHERE A RETROPERITONEAL BLEED WAS IDENTIFIED. THE PATIENT WAS TRANSFERRED TO CCU IN CRITICAL/UNSTABLE CONDITION. SHE DIED LATER THAT DAY. THE MYNX DEVICES HAVE BEEN TEMPORARILY PULLED OFF THE SHELVES PER PHYSICIAN (CATH LAB MEDICAL DIRECTOR). RUPTURE OF BALLOON THOUGHT TO BE DUE TO VESSEL CALCIFICATION, MANUAL COMPRESSION HELD FOR 20 MINUTES UNTIL HEMOSTASIS ACHIEVED. STENT PLACED IN LEFT MAIN FOUND TO BE PATENT, BUT PATIENT ABDOMEN DISTENDED, HARD, AND RIGHT COMMON FEMORAL ARTERY PSEUDOANEURYSM WITH NO ACTIVE BLEED WAS SEEN ON BILE ILIAC ANGIOGRAPHY. DESPITE VENTILATOR SUPPORT AND BLOOD PRODUCTS AND AGGRESSIVE RESUSCITATION EFFORTS, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC. * F1106902

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death