BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE (5F)

    MDR report key: 6506995 · Received April 20, 2017

    Report

    Report Number
    6506995
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    December 10, 2016
    Report Date
    April 18, 2017
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MYNX DEVICE FAILED. MYNX WENT INTO THE BODY AND BALLOON WAS BLOWN UP. DOCTOR PULLED BACK, PUSHED THE GREEN PART OF THE DEVICE DONE AND WHEN HE PULLED BACK THE SHEATH CAME AND SO DID THE PLUG. THE WHITE PORTION FAILED TO APPEAR AND THE PLUG APPEARS TO BE STUCK INSIDE THE DEVICE. THIS TYPE OF PROBLEM HAS BEEN OCCURRING AT THIS FACILITY FOR APPROXIMATELY 4 MONTHS. MULTIPLE PATIENTS AFFECTED, BUT NO PERMANENT HARM. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. THE CAUSE OF THE PROBLEM HAS NOT BEEN IDENTIFIED. MANUFACTURER RESPONSE FOR MYNX GRIP RMA (B)(4), MYNX GRIP (PER SITE REPORTER): WE RECEIVED THE FOLLOWING LETTER: THANK YOU FOR INFORMING US OF THE ISSUE WHICH OCCURRED WITH A MYNXGRIP AND IT HAS BEEN ENTERED INTO OUR SYSTEM TO FURTHER INVESTIGATE THIS ISSUE. THANK YOU FOR TAKING THE TIME TO REPORT THIS COMPLAINT TO US. MANUFACTURER RESPONSE FOR MYNX GRIP RMA (B)(4), MYNX GRIP (PER SITE REPORTER): WE RECEIVED THE FOLLOWING LETTER: THANK YOU FOR INFORMING US OF THE ISSUE WHICH OCCURRED WITH A MYNXGRIP AND IT HAS BEEN ENTERED INTO OUR SYSTEM TO FURTHER INVESTIGATE THIS ISSUE. THANK YOU FOR TAKING THE TIME TO REPORT THIS COMPLAINT TO US. MANUFACTURER RESPONSE FOR MYNX GRIP RMA (B)(4), (BRAND NOT PROVIDED) (PER SITE REPORTER): WE RECEIVED THE FOLLOWING LETTER: THANK YOU FOR INFORMING US OF THE ISSUE WHICH OCCURRED WITH A MYNXGRIP AND IT HAS BEEN ENTERED INTO OUR SYSTEM TO FURTHER INVESTIGATE THIS ISSUE. THANK YOU FOR TAKING THE TIME TO REPORT THIS COMPLAINT TO US. MANUFACTURER RESPONSE FOR MYNX GRIP RMA (B)(4), MYNX GRIP (PER SITE REPORTER): WE RECEIVED THE FOLLOWING LETTER: THANK YOU FOR INFORMING US OF THE ISSUE WHICH OCCURRED WITH A MYNXGRIP AND IT HAS BEEN ENTERED INTO OUR SYSTEM TO FURTHER INVESTIGATE THIS ISSUE. THANK YOU FOR TAKING THE TIME TO REPORT THIS COMPLAINT TO US. MANUFACTURER RESPONSE FOR MYNX GRIP (B)(4), MYNX GRIP (PER SITE REPORTER): WE RECEIVED THE FOLLOWING LETTER: THANK YOU FOR INFORMING US OF THE ISSUE WHICH OCCURRED WITH A MYNXGRIP AND IT HAS BEEN ENTERED INTO OUR SYSTEM TO FURTHER INVESTIGATE THIS ISSUE. THANK YOU FOR TAKING THE TIME TO REPORT THIS COMPLAINT TO US. MANUFACTURER RESPONSE FOR MYNX GRIP RMA (B)(4), MYNX GRIP (PER SITE REPORTER): WE RECEIVED THE FOLLOWING LETTER: THANK YOU FOR INFORMING US OF THE ISSUE WHICH OCCURRED WITH A MYNXGRIP AND IT HAS BEEN ENTERED INTO OUR SYSTEM TO FURTHER INVESTIGATE THIS ISSUE. THANK YOU FOR TAKING THE TIME TO REPORT THIS COMPLAINT TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290981 MYNXGRIP VASCULAR CLOSURE DEVICE (5F) DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY MX5021 F1627401

    Patients

    Seq Age Sex Outcome Treatment
    1 NO KNOWN