BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYBRID GUIDEWIRE WITH HYDROPHILIC COATING

    MDR report key: 14469860 · Received May 20, 2022

    Report

    Report Number
    MW5109809
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 17, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BALT USA, LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GUIDEWIRE BROKE IN THE LOOP. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293160 HYBRID GUIDEWIRE WITH HYDROPHILIC COATING WIRE, GUIDE, CATHETER DQX BALT USA, LLC HYBRID008D 00426371

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown