BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 8690653 · Received June 12, 2019

    Report

    Report Number
    3009984513-2019-00003
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    June 12, 2018
    Report Date
    June 12, 2019
    Manufacturer
    VASORUM LTD
    Product Code
    MGB
    UDI-DI
    05391530280068
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1- DURING THE PROCESSING OF THIS COMPLAINT ALL ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 2- THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM UNLESS OTHERWISE REQUESTED BY THE FDA. 3- VASORUM LTD IS SUBMITTING THIS REPORT ON BEHALF OF DJ MEDICAL CONSULTING & DISTRIBUTION LLC, IN ACCORDANCE WITH THE CONDITIONS OUTLINED WITH THE MDR EXEMPTION E2017048. VASORUM LTD TRINITAS HOUSE 2012 ORCHARD AVENUE CITYWEST BUSINESS PARK D24 WPW6 DUBLIN - IRELAND DJ MEDICAL CONSULTING AND DISTRIBUTION LLC 20 RYANS LANE DUXBURY MA 02332 USA

    Description of Event or Problem · 0

    ACCORDING TO THE DOCTOR, HE TURNED THE HANDLE CLOCKWISE, IT MADE THE 'CLICK', EVERYTHING SEEMED NORMAL BUT THE SET OF WINGS DIDN'T OPEN. WHEN PULLING BACK THE INSTRUMENT, THERE WAS NO RESISTANCE. DUE TO IMPLANT ERROR, ALSO DID NOT OPEN, THE SURGEON PULLED OUT THE CELT DEVICE BUT MANAGED TO LEAVE THE INTRODUCER SHEATH INSIDE AND CLOSED WITH AN ANGIO-SEAL DEVICE. THIS WAS A CARDIAC PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485149 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD KCLT-06 478046 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention