BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAK-NV MICROPUNCTURE KIT

    MDR report key: 16856474 · Received May 2, 2023

    Report

    Report Number
    3011642792-2023-00031
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 21, 2023
    Report Date
    April 21, 2023
    Manufacturer
    MERIT MEDICAL SYSTEMS MEXICO
    Product Code
    GCB
    UDI-DI
    00884450088838
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT MEDICAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INVESTIGATED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED. SHOULD THE DEVICE BE RETURNED LATER, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO MANEUVER AROUND A KIDNEY STONE. THE FRONT END OF THE CATHETER NEAR THE RADIOPAQUE MARKER DETACHED. THE DEVICE REMAINED ON THE GUIDEWIRE AND WAS RETRIEVED ALONG WITH THE GUIDEWIRE. NO ADDITIONAL INTERVENTION PROCEDURE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799700 MAK-NV MICROPUNCTURE KIT MICRO NEEDLE, CATHETER GCB MERIT MEDICAL SYSTEMS MEXICO MAK-NV-013/B I235864 00884450088838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ACCESS GUIDEWIRE