BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANGIO-SEAL VASCULAR CLOSURE DEVICE,OUS

    MDR report key: 17347728 · Received July 18, 2023

    Report

    Report Number
    3013394970-2023-00304
    Event Type
    Injury
    Date Received
    July 18, 2023
    Report Date
    July 18, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP # 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED FOR A CLOSURE-RELATED ISSUE. THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN EXCESSIVE FORCE OR INCORRECT DEPLOYMENT TECHNIQUE RESULTING IN A COMPLICATION DURING SURGERY. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED DUE TO THE PRODUCT CODE AND LOT NUMBER BEING UNKNOWN. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FMEA.

    Additional Manufacturer Narrative · 0

    THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WILL NOT BE CONDUCTED. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    A LITERATURE ARTICLE FROM THE JOURNAL OF COLLEGE ANGIOLOGY. 2023; 63(2): 23-6 REPORTED; A CASE OF ACUTE ARTERIAL DISSECTION CAUSED BY A HEMOSTATIC DEVICE AND SURGERY. HEMOSTASIS FAILURE, CHILL, THROMBOEMBOLISM AND VASCULAR DISSECTION AND ADDITIONAL SURGICAL OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42776 UNKNOWN ANGIO-SEAL VASCULAR CLOSURE DEVICE,OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R