BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR SOLUTIONS, INC

    MDR report key: 5945868 · Received September 9, 2016

    Report

    Report Number
    MW5064682
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 14, 2016
    Report Date
    August 24, 2016
    Manufacturer
    VASCULAR SOLUTIONS, INC.
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VASCULAR SOLUTION STENT DEPLOYED IN THE LAO AND THE TIP BROKE OFF AND REMAINS LODGED IN THE VESSEL. THE CATHETER IS IN THE VEIN GRAFT. IT SHEARED OFF DURING THE PROCEDURE. IT IS NOT COMPROMISING FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591801 VASCULAR SOLUTIONS, INC CORONARY STENT NIQ VASCULAR SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization