BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 23999995 · Received January 7, 2026

    Report

    Report Number
    3016444913-2025-00003
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    July 20, 2025
    Report Date
    January 7, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    PMA / PMN Number
    K220383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURY WAS ASSOCIATED WITH THE REPORTED INCIDENT, AND NO MEDICAL INTERVENTION WAS REQUIRED; THE DEVICE WAS LEFT IN SITU WITHOUT CLINICAL SEQUELAE. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NEITHER AN INVESTIGATION NOR A MANUFACTURING REVIEW COULD BE CONDUCTED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT FOLLOWING PLACEMENT AND DEPLOYMENT OF A LOBO VASCULAR OCCLUSION SYSTEM DEVICE (MODEL LOBO-7) DURING A SPLENIC ARTERY EMBOLIZATION PROCEDURE, THE DEVICE REMAINED STABLE AT THE INTENDED LOCATION. AFTER APPROXIMATELY ONE (1) MINUTE, THE DEVICE ALLEGEDLY APPEARED TO MOVE DISTALLY, WITH A SUBSEQUENT DISTAL MOVEMENT OCCURING APPROXIMATELY TWO (2) MINUTES LATER. THE TOTAL DISTAL DISPLACEMENT WAS ESTIMATED TO BE APPROXIMATELY 8-9CM, AT WHICH POINT THE DEVICE STABILIZED AT A BIFURCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59710 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-7 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male