BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 24673375 · Received March 24, 2026

    Report

    Report Number
    3009984513-2026-00005
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 24, 2026
    Manufacturer
    VASORUM LTD
    Product Code
    MGB
    UDI-DI
    05391530280617
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT AN ATTEMPT WAS MADE TO OBTAIN COMPLETE EVENT INFORMATION. A SEARCH OF THE COMPLAINT FILES WAS COMPLETED, AND NO OTHER COMPLAINTS WERE IDENTIFIED WITH THE SAME LOT NUMBER. THE DEVICE WAS NOT RETURNED TO VASORUM LTD FOR EXAMINATION. THE IMPLANT REMAINS IN THE PATIENT. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED THE FOLLOWING DAY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD. FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM LTD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED CLOSURE WITH 5F CELT ACD PLUS. DURING CLOSURE THE OPERATOR PERFORMED STEP 1 AND 2 OF DEPLOYMENT UNDER ULTRASOUND GUIDANCE AND UTILIZING THE BLOOD SIGNAL, BUT WHEN ATTEMPTED TO EJECT/DETACH THE IMPLANT THE LEVER WOULDN'T MOVE WITH THE USUAL FORCE APPLIED. OPERATOR THEN INCREASED THE PRESSURE AND THE IMPLANT DETACHED AND MIGRATED DOWNSTREAM, BECOMING LODGED IN A SIDE BRANCH OF THE SUPERFICIAL FEMORAL ARTERY. THE CLOSURE PROCEDURE WAS COMPLETED WITH MANUAL PRESSURE AND HEMOSTASIS WAS ACHIEVED. PATIENT WAS STABLE AND DISCHARGED SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736051 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD CLT-05 943609 05391530280617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other