BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 16617856 · Received March 27, 2023

    Report

    Report Number
    3009984513-2023-00002
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    February 22, 2023
    Report Date
    April 14, 2023
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280068
    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 WAS NOT POSSIBLE AS LOT NUMBER WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RETURNED TO VASORUM LTD FOR ANALYSIS. NO ISSUES WITH THE DEVICE WERE IDENTIFIED. A SEARCH OF THE COMPLAINT'S FILES FOUND ONE OTHER REPORT (MDR 3009984513-2021-00013) WITH THE INVOLVED LOT NUMBER. THERE WAS NO EVIDENCE TO SUGGEST THE TWO EVENTS WERE RELATED. 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 UNLESS OTHERWISE REQUESTED BY THE FDA..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON ATTEMPTING TO USE THE CELT ACD DEVICE TO CLOSE A 6F ARTERIAL PUNCTURE, THE CUSTOMER THOUGHT THAT THE DISTAL WING WAS OPEN BUT WHEN ATTEMPTING TO WITHDRAW TO THE ARTERIOTOMY THE DEVICE SLIPPED OUT OF THE PATIENT. IT WAS NOTED THAT THE DISTAL WINGS DID NOT OPEN. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS AND THE PATIENT WAS DISCHARGED ON TIME WITHOUT INCIDENT. NO DEVICE WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON ATTEMPTING TO USE THE CELT ACD DEVICE TO CLOSE A 6F ARTERIAL PUNCTURE, THE CUSTOMER THOUGHT THAT THE DISTAL WING WAS OPEN BUT WHEN ATTEMPTING TO WITHDRAW TO THE ARTERIOTOMY THE DEVICE SLIPPED OUT OF THE PATIENT. IT WAS NOTED THAT THE DISTAL WINGS DID NOT OPEN. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS AND THE PATIENT WAS DISCHARGED ON TIME WITHOUT INCIDENT. NO DEVICE WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835616 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 883954 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention