BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL INC VASCADE MVP VASCLAUR CLSOURE DEVICE

    MDR report key: 18434468 · Received January 3, 2024

    Report

    Report Number
    3004182619-2024-00002
    Event Type
    Injury
    Date Received
    January 3, 2024
    Report Date
    January 2, 2024
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE THE DEVICE WAS NOT RETURNED FOR PHYSICAL INVESTIGATION, ARTERIO-VENOUS FISTULA ARE COMPLICATIONS, WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE. THE AV FISTULA REQUIRED SURGERY TO CORRECT. THERE IS NO REPORT OF DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    THE VASCADE MVP DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE 11F SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. THE PUSH ROD WAS UTILIZED TO STRIP THE COLLAGEN FROM THE DEVICE, AND THE DEVICE WAS REMOVED. AT SOME POINT, POST PROCEDURE PATIENT WAS DIAGNOSED WITH ARTERIO-VENOUS FISTULA, WHICH REQUIRED SURGERY TO CORRECT. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762642 CARDIVA MEDICAL INC VASCADE MVP VASCLAUR CLSOURE DEVICE VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention