BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYNX VASCULAR

    MDR report key: 6649519 · Received June 19, 2017

    Report

    Report Number
    6649519
    Event Type
    Death
    Date Received
    June 19, 2017
    Date of Event
    June 8, 2017
    Report Date
    June 15, 2017
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATH LAB PACU HAS HAD X3 ADVERSE OUTCOMES, POTENTIALLY TIED TO CLOSURE DEVICE USED, RESULTING IN X1 DEATH, AND X2 SERIOUS INJURY. ALL PATIENTS WITH LOW BP SEVERAL HOURS AFTER CATH PROCEDURE. NO INDICATION IN CHARTING OF DIFFICULTY WITH DEVICE. ROOT CAUSE OF FAILURE ONGOING AT FACILITY.

    Description of Event or Problem · 1

    CATH LAB PACU HAS HAD X3 ADVERSE OUTCOMES, POTENTIALLY TIED TO CLOSURE DEVICE USED, RESULTING IN X1 DEATH, AND X2 SERIOUS INJURY. ALL PATIENTS WITH LOW BP SEVERAL HOURS AFTER CATH PROCEDURE. NO INDICATION IN CHARTING OF DIFFICULTY WITH DEVICE. ROOT CAUSE OF FAILURE ONGOING AT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430014 MYNX VASCULAR DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY MX6721 F1709603

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| R