BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 14247786 · Received April 29, 2022

    Report

    Report Number
    3009984513-2022-00005
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 29, 2022
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    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 COMPLAINTS DIDN'T FIND ANY OTHER COMPLAINT WITH LOT NUMBER PROVIDED. THE INVESTIGATION WAS BASED ON THE USER FACILITY INFORMATION. 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 · 0

    IT WAS REPORTED THAT A USER ATTEMPTED TO USE A 6F CELT DEVICE TO CLOSE A 6F ARTERIAL PUNCTURE. IMMEDIATELY THE USER REPORTED THAT A HAEMATOMA FORMED AFTER DEPLOYMENT. UPON FLUOROSCOPY EXAMINATION IT WAS NOTED THAT THE CELT IMPLANT WAS IN THE SUPERFICIAL FEMORAL ARTERY. EXAMINATION OF PULSES IN THE LEG BY DOPPLER ULTRASOUND SHOWED THAT THE PULSES WERE PRESENT. THE CLINICIAN INVOLVED IN THE INCIDENT DECIDED TO ACCESS THE DORSALIS PEDIS IN THE FOOT AND PERFORM AN ANGIOGRAM IN ADDITION TO AN INTRAVASCULAR ULTRASOUND EXAMINATION. IT WAS CONFIRMED THAT THE CELT WAS INTRAVASCULARLY DEPLOYED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE CLINICIAN DECIDED THAT THE IMPLANT WAS CAUSING A SEVERE STENOSIS OF THE ARTERY AND ELECTED TO USE A 5MM COVERED STENT TO COVER THE CELT IMPLANT IN THE SUPERFICIAL FEMORAL ARTERY. THE CLINICIAN THEN DILATED THE COVERED STENT USING A 5MM BALLOON. THE PROCEDURE WAS SUCCESSFUL, AND THE TIBIAL ACCESS WAS MANAGED WITH MANUAL COMPRESSION. THE PATIENT WAS THEN DISCHARGED WITH NO FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98396 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention