BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE

    MDR report key: 12567704 · Received October 4, 2021

    Report

    Report Number
    12567704
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 17, 2021
    Report Date
    September 22, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    GYA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SURGEON UTILIZED A ZIPWIRE FOR ACCESS DURING A QUINTON CATHETER INSERTION. IT WAS NOTED THAT THE WIRE COATING SHEARED OFF DURING ACCESS. THE COATING REMAINED ATTACHED TO WIRE UPON REMOVAL, NO COATING WAS NOTED AT THE INSERTION SITE, AND NO FOREIGN OBJECT OR WIRE WAS NOTED ON THE C-ARM X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470470 ZIPWIRE TESTER, ELECTRODE/LEAD, ELECTROENCEPHALOGRAPH GYA LAKE REGION MEDICAL M006630205B0 6146672

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA