BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR DEVICE

    MDR report key: 23665446 · Received November 27, 2025

    Report

    Report Number
    3009984513-2025-00010
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    October 3, 2025
    Report Date
    November 24, 2025
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280068
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 COMPLAINT HAD NOT BEEN PREVIOUSLY REPORTED. THE DEVICE WAS NOT RETURNED TO VASORUM LTD. FOR EXAMINATION. IT WAS SUBSEQUENTLY REPORTED THAT THE IMPLANT WAS EXPLANTED, AND 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

    THE FOLLOWING WAS REPORTED THROUGH MEDWATCH (MW5177699) "AFTER A LEFT HEART CATHETERIZATION, IT WAS DECIDED TO USE A CLOSURE DEVICE TO CLOSE THE FEMORAL ARTERIOTOMY. DURING DEPLOYMENT OF CELT 6F DEVICE, THE FOOTPLATE BROKE OFF AND EMBOLIZED DOWN THE LEG. REQUIRED VASCULAR SURGERY INTERVENTION TO REMOVE THE FOOTPLATE". FOLLOW UP INVESTIGATION INDICATED THE IMPANT WAS EMBOLIZED. SNARE RETRIEVAL WAS UNSUCCESSFUL. THE IMPLANT WAS SUCCESSFULLY REMOVED SURGICALLY. THE PATIENT WAS STABLE AFTER THE SURGERY AND DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807326 CELT ACD VASCULAR DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 943220 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization| R