BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD PLUS VASCULAR CLOSURE DEVICE

    MDR report key: 22183532 · Received June 11, 2025

    Report

    Report Number
    3009984513-2025-00007
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    March 10, 2025
    Report Date
    June 11, 2025
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280679
    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. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943124). THE DEVICE WAS NOT RETURNED TO VASORUM LTD. FOR EXAMINATION. ATTEMPTS TO OBTAIN FINAL PATIENT STATUS WERE UNSUCCESSFUL OTHER THAN IT BEING REPORTED THAT THE SNARING PROCEDURE WAS SUCCESSFUL. IT WAS NOT DETERMINED IF THE HOSPITAL HAD ACTUALLY SUBMITTED THE MEDWATCH REPORT TO THE FDA. AS THE TIME OF CLOSING OUT THIS EVENT, VASORUM LTD DID NOT IDENTIFY OR RECEIVE ANY OFFICIAL FDA MEDWATCH CORRESPONDENCE. 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

    A MEDWATCH REPORT FORM WAS RECEIVED WHICH STATED THAT THE 6F CELT ACD CLOSURE DEVICE WAS MAL-DEPLOYED AND INTRALUMINAL IN THE RIGHT COMMON FEMORAL ARTERY. THE MAL-DEPLOYED CLOSURE DEVICE WAS IMMEDIATELY RETRIEVED SUCCESSFULLY. AN UPDATE WAS RECEIVED ON (B)(6) 2025 INFORMING THAT THE EMBOLIZED IMPLANT WAS RETRIEVED SUCCESSFULLY BY A SNARE. ATTEMPTS TO OBTAIN FINAL PATIENT STATUS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82188 CELT ACD PLUS VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 943124 05391530280679

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Female Required Intervention