BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 16617855 · Received March 27, 2023

    Report

    Report Number
    3009984513-2023-00003
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    February 27, 2023
    Report Date
    May 24, 2023
    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 FILES DIDN'T FIND ANY OTHER COMPLAINT WITH POSSIBLE ASSOCIATED LOT NUMBERS (919610 OR 942775). THE DEVICE HAS BEEN RETURNED TO VASORUM LTD FOR ANALYSIS. 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 FINAL REPORT BEING SUBMITTED BY VASORUM LTD UNLESS OTHERWISE REQUESTED BY THE FDA. INVESTIGATION CONCLUSION CODE 4316 WAS USED AS NO OTHER FEASIBLE CODE WAS FOUND FOR THE PREFERRED TERM "UNDETERMINABLE/NOT CONFIRMED".

    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 FILES FOUND ANY OTHER COMPLAINT ((B)(4)) WITH THE ASSOCIATED LOT NUMBER. THE DEVICE IS BEING RETURNED TO VASORUM LTD RETURNED FOR ANALYSIS. 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 BY VASORUM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON USING THE 6F CELT ACD DEVICE TO CLOSE A 6F ARTERIAL PUNCTURE, BOTH THE DISTAL AND PROXIMAL WINGS DEPLOYED SUCCESSFULLY AT THE ARTERIOTOMY. HOWEVER, WHEN PRESSING THE LEVER TO EJECT, THE IMPLANT WOULD NOT DETACH FROM THE DELIVERY SYSTEM. THE SHEATH AND THE DELIVERY SYSTEM WITH THE UNDEPLOYED IMPLANT WERE REMOVED FROM THE PATIENT AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT HAD NO COMPLICATIONS AND WAS DISCHARGED WITHOUT ANY DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON USING THE 6F CELT ACD DEVICE TO CLOSE A 6F ARTERIAL PUNCTURE, BOTH THE DISTAL AND PROXIMAL WINGS DEPLOYED SUCCESSFULLY AT THE ARTERIOTOMY. HOWEVER, WHEN PRESSING THE LEVER TO EJECT, THE IMPLANT WOULD NOT DETACH FROM THE DELIVERY SYSTEM. THE SHEATH AND THE DELIVERY SYSTEM WITH THE UNDEPLOYED IMPLANT WERE REMOVED FROM THE PATIENT AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT HAD NO COMPLICATIONS AND WAS DISCHARGED WITHOUT ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835615 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention