BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 3022601 · Received March 14, 2013

    Report

    Report Number
    3022601
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 7, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ACCESS CLOSURE INC
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH ULCERATIONS AND PERIPHERAL VASCULAR DISEASE UNDERWENT LOWER EXTREMITY ANGIOGRAPHY AND STENTING. AT END THE CASE A MYNX CLOSURE DEVISE DEPLOYED. HOWEVER HEMATOMA DEVELOPED. MANUAL COMPRESSION X 1 HOUR. 2ND PROCEDURE REQUIRED WITH STENTING. PSEUDOANEURYSM NOTED. 2ND CLOSURE DEVICE SUCCESSFULLY DEPLOYED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LOWER EXTREMITY ANGIOGRAPHY AND STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108324 MYNXGRIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE INC 8013131130F1233304LK F1233304

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R OTHER