BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOS CORPORATION

    MDR report key: 3519091 · Received December 9, 2013

    Report

    Report Number
    MW5033326
    Event Type
    Injury
    Date Received
    December 9, 2013
    Date of Event
    November 9, 2013
    Report Date
    December 2, 2013
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THROMBOLYSIS F/U A CATHETER WAS REMOVED. UPON ADD'L IMAGING, A WIRE WAS NOTICED INSIDE THE ARTERY. THIS WAS RETRIEVED BY SNARE. IT WAS A PIECE OF THE INNER CORE OF AN EKOS INFUSION CATHETER. THE INNER CORE HAD BEEN REMOVED THE PREVIOUS EVENING. HISTORY OF DIABETES TYPE 2, CORONARY ARTERY DISEASE, COPD, LYMPHEDEMA, PERIPHERAL VASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638038 EKOS CORPORATION EKOS INFUSION CATHETER KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention