BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE

    MDR report key: 11892878 · Received May 27, 2021

    Report

    Report Number
    11892878
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 17, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    GYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ZIPWIRE GENERAL-PURPOSE NON-VASCULAR GUIDEWIRE WAS BEING USED TO GUIDE INTO THE PATIENT RIGHT URETER FOR A STENT EXCHANGE AND LITHOTRIPSY. THE ZIPWIRE GUIDEWIRE WAS FOUND TO BE SEVERED, CONFIRMED THROUGH FLUOROSCOPY. THE GUIDEWIRE WAS RETRIEVED IMMEDIATELY BY THE SURGEON, AND THE STENT WAS PLACED AS PLANNED. NO HARM TO THE PATIENT WAS IDENTIFIED, ONLY EXTENDING THE LENGTH OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790500 ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH GYA LAKE REGION MEDICAL M006630208B0 5975145

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA