BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY

    MDR report key: 7809530 · Received August 22, 2018

    Report

    Report Number
    MW5079351
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    August 20, 2018
    Report Date
    August 21, 2018
    Manufacturer
    EDWARD LIFESCIENCES LLC
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A THROMBECTOMY PROCEDURE, THE SURGEON USED A 3 FR EMBOLECTOMY CATHETER. THE SURGEON INSERTED THE CATHETER AND ENCOUNTERED RESISTANCE WHEN REMOVING. ONCE REMOVED, THE STAFF NOTICED THAT THE TIP OF CATHETER WAS MISSING. NO DEFECTS NOTED IN CATHETER PRIOR TO USE. INCIDENT OCCURRED DURING FIRST PASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645531 FOGARTY CATHETER, EMBOLECTOMY DXE EDWARD LIFESCIENCES LLC EMB80 61361068

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention