BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE

    MDR report key: 12369865 · Received August 26, 2021

    Report

    Report Number
    12369865
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    August 18, 2021
    Report Date
    August 20, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    GYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRAGMENT OF THE GLIDEWIRE USED TO PLACE THE R SUBCLAVIAN CVL SHEARED OFF THE DEVICE AND WAS RETAINED IN THE CENTRAL VENOUS SYSTEM FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266400 ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH GYA LAKE REGION MEDICAL M006630200B0 6090560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other