BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 20829593 · Received December 3, 2024

    Report

    Report Number
    3009984513-2024-00013
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 13, 2024
    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
    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. THERE WERE NO REPORTED HEALTH CONSEQUENCES OR IMPACT FOR THE PATIENT ASSOCIATED TO THIS EVENT. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943118). THE DEVICE WAS RETURNED TO VASORUM LTD. FOR EXAMINATION. THERE WERE NO FAULTS OR DEFECTS IDENTIFIED WITH THE CELT 6F DEVICE OR ITS COMPONENTS. 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.

    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 (943118). THE DEVICE IS BEING 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. THIS REPORT IS THE INITIAL REPORT BEING SUBMITTED. HEALTH EFFECT - CLINICAL CODE 4581 WAS USED AS NO OTHER FEASIBLE CODE WAS FOUND FOR THE PREFERRED TERM "BLEEDING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PHYSICIAN DEPLOYED THE 6F CELT ON A 6F SHEATH. BLEEDING WAS NOTED UPON EJECTION. MANUAL COMPRESSION WAS APPLIED. ON FLUOROSCOPY IT WAS NOTED THAT THE IMPLANT WAS EMBOLIZED INTO THE TP TRUNK. DESPITE THE PATIENT HAVING ADEQUATE PULSES, VASCULAR SURGERY ELECTIVELY DECIDED TO RETRIEVE THE IMPLANT USING AN ENDOVASCULAR SNARE. THE PATIENT WAS ADMITTED TO THE ICU FOR HIGH BLOOD PRESSURE (NOT RELATED TO THE INCIDENT WITH THE CLOSURE DEVICE) AND WAS DISCHARGED WITH NO GROIN COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PHYSICIAN DEPLOYED THE 6F CELT ON A 6F SHEATH. BLEEDING WAS NOTED UPON EJECTION. MANUAL COMPRESSION WAS APPLIED. ON FLUOROSCOPY IT WAS NOTED THAT THE IMPLANT WAS EMBOLIZED INTO THE TP TRUNK. DESPITE THE PATIENT HAVING ADEQUATE PULSES, VASCULAR SURGERY ELECTIVELY DECIDED TO RETRIEVE THE IMPLANT USING AN ENDOVASCULAR SNARE. THE PATIENT WAS ADMITTED TO THE ICU FOR HIGH BLOOD PRESSURE (NOT RELATED TO THE INCIDENT WITH THE CLOSURE DEVICE) AND WAS DISCHARGED WITH NO GROIN COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543979 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 943118 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention