BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 12023282 · Received June 18, 2021

    Report

    Report Number
    3009984513-2021-00012
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    June 3, 2021
    Report Date
    June 18, 2021
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280228
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A REVIEW OF THE LOT RECORD WAS CONDUCTED WITH NO RELEVANT FINDINGS. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM UNLESS OTHERWISE REQUESTED BY THE FDA. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCIDENT OCCURRED AFTER THE DR ATTEMPTED TO CLOSE A PUNCTURE MADE BY A 7F SHEATH WITH A 7F CELT CLOSURE DEVICE. UPON COMPLETION OF THE FINAL STEP BLEEDING WAS NOTED BY THE PHYSICIAN. MANUAL PRESSURE WAS APPLIED AND HEMOSTASIS WAS ACHIEVED. THE PHYSICIAN THEN USED FLUOROSCOPY AND ULTRASOUND AND DETERMINED THAT THE IMPLANT WAS DEPLOYED WITHIN THE LUMEN OF THE COMMON FEMORAL ARTERY, WHERE IT REMAINED. THE PHYSICIAN ELECTED TO DO A SURGICAL CUT DOWN AND REMOVE THE IMPLANT. THE IMPLANT WAS EASILY LOCATED IN THE COMMON FEMORAL ARTERY AND REMOVED. THE PATIENT WAS DISCHARGED ON TIME WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924584 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-07 814024 05391530280228

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention