BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 21855062 · Received April 17, 2025

    Report

    Report Number
    3009984513-2025-00005
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 17, 2025
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280129
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943142). THE DEVICE WAS NOT RETURNED TO VASORUM LTD. FOR EXAMINATION. 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 UNLESS REQUESTED BY THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 7F CELT ACD DEVICE WAS DEPLOYED AT THE END OF THE PROCEDURE. UPON EJECTION THE IMPLANT MIGRATED TO THE POPLITEAL ARTERY. PATIENT WAS TAKEN TO THE SURGERY AND THE IMPLANT WAS REMOVED. PATIENT WAS REPORTED TO HAVE NO COMPLICATIONS AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682129 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-07 943142 05391530280129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention