BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 21362097 · Received February 12, 2025

    Report

    Report Number
    3009984513-2025-00003
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 11, 2025
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280068
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE PATIENT REQUIRED AN ADDITIONAL SNARE PROCEDURE TO REMOVE THE EMBOLIZED IMPLANT. THE PHYSICIAN WAS ABLE TO DO SO SUCCESSFULLY WITH NO ADVERSE EVENT/COMPLICATIONS TO THE PATIENT. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943101). 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 5F CELT DEVICE WAS USED TO CLOSED A 5F ARTERIAL PUNCTURE. UPON EJECTION OF THE IMPLANT IT WAS NOTED THAT THE CLOSURE DIDN'T WORK AND MANUAL COMPRESSION WAS APPLIED. DURING THE MANUAL COMPRESSION STEP, THE ATTENDING PHYSICIAN ELECTED TO RETRIEVE THE IMPLANT BY ACCESSING THE OPPOSITE GROIN TO GO UP AND OVER AND SNARE THE IMPLANT. THE PHYSICIAN WAS ABLE TO COMPLETE SNARING OF IMPLANT SUCCESSFULLY WITH NO ADVERSE EVENTS/COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904013 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-05 943101 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention