BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 11715228 · Received April 23, 2021

    Report

    Report Number
    3009984513-2021-00005
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 24, 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 · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE LOT RECORD FOUND 1 OTHER COMPLAINT WITH SAME LOT NUMBER. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. CODE FOR INVESTIGATION FINDINGS CHOSEN WAS 4247 AS THERE WAS NO OTHER FEASIBLE CODE FOR THE INVESTIGATION FINDING OF "RELATED TO THE PATIENTS CONDITION AND INFLUENCED BY USE OF THE DEVICE" CODE FOR INVESTIGATION CONCLUSION CHOSEN WAS 4316 AS THERE WAS NO OTHER FEASIBLE CODE FOR THE INVESTIGATION CONCLUSION OF ""RELATED TO THE PATIENT'S CONDITION AND INFLUENCED BY USE OF THE DEVICE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CELT ACD DEVICE WAS USED TO CLOSE A PUNCTURE IN A VEIN GRAFT, WHICH WAS LOCATED IN THE FEMORAL POSITION. AFTER OPENING THE DISTAL WINGS OF THE IMPLANT IT APPEARED TO GRAB THE BACK WALL OF THE VASCULAR GRAFT AND WOULD NOT RELEASE FROM THE BACK WALL. AFTER TRYING MULTIPLE STEPS DR PULLED THE IMPLANT BACK THROUGH THE PUNCTURE SITE AND OPENED THE PROXIMAL WINGS. HAEMOSTASIS WAS NOTED AND DR THEN PROCEEDED TO PERFORM AN ANGIOGRAM ABOVE THE PUNCTURE SITE BY PERFORMING A MICRO PUNCTURE AT A HIGHER LEVEL IN THE VESSEL. THIS REVEALED THAT THE BACK WALL OF THE GRAFT WAS ATTACHED TO THE INTERNAL WING AND BLOOD FLOW WAS LIMITED. DR THEN INTRODUCED A GUIDEWIRE AND AN ANGIOPLASTY BALLOON TO OPEN THE VESSEL AT THE SITE OF THE CAPTURE OF THE BACK WALL OF THE GRAFT. THIS MANOEUVRE WAS SUCCESSFUL IN RESTORING DISTAL BLOOD FLOW TO THE LEG AND MANUAL COMPRESSION WAS PERFORMED AT THE SITE OF THIS HIGHER PUNCTURE SITE. THE PATIENT WAS DISCHARGED WITHIN AN HOUR.

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE LOT RECORD FOUND 1 OTHER COMPLAINT WITH SAME LOT NUMBER. THIS REPORT IS THE INITIAL REPORT BEING SUBMITTED BY VASORUM. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER COMPLETION OF THE INVESTIGATION. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLOSURE WAS DONE WITH LONGITUDINAL ULTRASOUND. DR PULLED BACK TO CLOSE ARTERIOTOMY THEN OPENED #1 WHICH GRABBED THE BACK WALL (GRAFT) AND WOULDN'T BREAK FREE. AFTER TRYING MULTIPLE STEPS TO FREE IT, DR PULLED UP TO PLACE DISC AND PROCEEDED TO #2 AND 3. HEMOSTASIS WAS NOTED AND THEN DR ACCESSED ABOVE THE SITE WITH MICROPUNCTURE AND PERFORMED AN ANGIOGRAM TO SEE THAT BACK WALL WAS ATTACHED TO INTERNAL WING AND BLOOD FLOW WAS LIMITED. DR PERFORMED WIRE/BALLOON TO OPEN VESSEL. IMPLANT WAS NOT REMOVED. MANUAL COMPRESSION WAS PERFORMED TO ACHIEVE HEMOSTASIS. PATIENT WAS DISCHARGED IN 1 HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609392 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 836168 05391530280228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention