BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 24599401 · Received March 13, 2026

    Report

    Report Number
    3016444913-2025-00005
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 13, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    PMA / PMN Number
    K220383
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INJURY WAS ASSOCIATED WITH THE REPORTED INCIDENT. THE PHYSICIAN PLACED GEL FOAM BEHIND THE LOBO-7 DEVICE TO ASSIST IN OCCLUSION AND COMPLETE THE PROCEDURE, WITHOUT FURTHER INCIDENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; A DEVICE HISTORY RECORD REVIEW REVEALED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS AND ACCEPTABLE PARAMETERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PHYSICIAN WAS TREATING A NON-ACTIVE SPLENIC BLEED WITH A LOBO-7 VASCULAR OCCLUSION SYSTEM DEVICE. IT WAS REPORTED THAT THE TARGET VESSEL WAS MEASURED TO BE AROUND 5-6 MM IN DIAMETER. UPON DETACHMENT OF THE LOBO-7 DEVICE, IT WAS REPORTED THAT THE DEVICE MIGRATED APPROXIMATELY 20-30 MM. THE PHYSICIAN PERFORMED SEVERAL ANGIOGRAMS AFTER THE DEVICE WAS DEPLOYED AND IT WAS REPORTED THAT THERE APPEARED TO STILL BE SOME FLOW GOING THROUGH THE LOBO-7 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656274 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-7 25H0002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other