BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOBO VASCULAR OCCLUSION SYSTEM

    MDR report key: 25062341 · Received May 1, 2026

    Report

    Report Number
    3016444913-2026-00010
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 1, 2026
    Manufacturer
    OKAMI MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00850008220611
    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 AND AND NO ADVERSE EFFECTS TO THE PATIENT. THE LOBO-9 DEVICE WAS ABLE TO REENGAGE THE VESSEL WALL AND OCCLUDE SPLEEN WITHOUT THE USE OF ANCILLARY DEVICES. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND NO LOT NUMBER WAS PROVIDED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A DHR REVIEW OF THE LOT NUMBER ASSOCIATED WITH THE DEVICE REVEALED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LOBO-9 DEVICE WAS ADVANCED THROUGH A GUIDE CATHETER DURING A SPLENIC EMBOLIZATION PROCEDURE. THE FIRST LOBE WAS DEPLOYED AND THE SECOND LOBE WAS PARTIALLY UNSHEATHED PRIOR TO DETACHMENT. THE TARGET VESSEL MEASURED APPROXIMATELY 8 MM IN DIAMETER BASED ON CT AND ANGIOGRAPHIC ASSESSMENT. UPON DETACHMENT, THE DEVICE REPORTEDLY MIGRATED DISTALLY WITHIN THE SPLENIC VASCULATURE, ADVANCING APPROXIMATELY 2 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30948 LOBO VASCULAR OCCLUSION SYSTEM VASCULAR EMBOLIZATION DEVICE KRD OKAMI MEDICAL INC. LOBO-9 25L0003 00850008220611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other