BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 24613622 · Received March 16, 2026

    Report

    Report Number
    3016444913-2026-00007
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    April 25, 2023
    Report Date
    March 16, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    PMA / PMN Number
    K192083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICIAN DECIDED TO USE TWO MORE DOSES OF #9 PARTICLES. HE THEN PLACED A SECOND LOBO-3 PROXIMALLY WHICH WAS ALSO IMMEDIATELY OCCLUSIVE. THE PHYSICIAN ASSESSED THE DEVICE POSITION AND ELECTED TO LEAVE IT IN PLACE AS IT WAS PERFORMING ITS INTENDED FUNCTION TO OBSTRUCT OR REDUCE FLOW IN THE ARTERY AND DID NOT POSE A SAFETY RISK. NO FURTHER FOLLOW-UP WAS REQUIRED AS DETERMINED BY THE PHYSICIAN. MOVEMENT OF THE DEVICE WAS ATTRIBUTED TO USE ERROR, WHERE THE PHYSICIAN DID NOT FOLLOW THE LABELED INSTRUCTIONS FOR USE ("ENSURE THE TARGETED VESSEL MEETS THE RECOMMENDED DIAMETER") AND PROCEEDED TO PLACE LOBO-3 IN A 3.1 MM VESSEL, ABOVE THE LABELED USE VESSEL DIAMETER RANGE OF 1.5 TO 3.0 MM. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO INVESTIGATION COULD BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A VERY LARGE UTERINE FIBROID UNDERWENT UTERINE ARTERY EMBOLIZATION. THE TREATMENT PLAN INCLUDED EMBOLIZATION WITH PARTICLES FOLLOWED BY VESSEL OCCLUSION USING A LOBO-3 DEVICE. THE UTERINE ARTERIES WERE NOTED TO BE UNUSUALLY LARGE AND EXTREMELY TORTUOUS. IN THE FIRST ARTERY, PARTICLES (#5 AND #7) WERE INJECTED, AND A LOBO-3 DEVICE WAS DEPLOYED IN A VESSEL MEASURED AT APPROXIMATELY 3.1 MM. THE DEVICE MIGRATED APPROXIMATELY 13 MM AFTER PLACEMENT BUT WAS IMMEDIATELY OCCLUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675077 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-3

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other