BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP VCS

    MDR report key: 23521879 · Received November 11, 2025

    Report

    Report Number
    3011469355-2025-00046
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    September 9, 2025
    Report Date
    November 11, 2025
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED BY THE USER FACILITY, AND NO SERIAL NUMBER WAS PROVIDED. AS A RESULT, THE DEVICE'S MANUFACTURING RECORDS CANNOT BE REVIEWED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. INFECTION IS A KNOWN, POSSIBLE RISK WITH AN INCISION WHICH IS DISCLOSED IN THE PRODUCT IFU. THE INSTRUCTION MANUAL FOR THE VASCADE MVP STATES "WARNING DO NOT RELEASE THE COLLAGEN PATCH IF ANY PART OF THE WHITE MARKER STRIPE IS SHOWING (E.G. TISSUE TRACT IS TOO SHORT), AS THIS MAY INCREASE THE RISK OF INFECTION IF THE COLLAGEN PROTRUDES FROM THE SKIN."

    Description of Event or Problem · 0

    A PATIENT UNDERWENT AN ABLATION PROCEDURE UTILIZING THE VASCADE MVP CLOSURE DEVICE, WHICH WAS DEPLOYED THROUGH AN 8 FR SHEATH. NO DEVICE ANOMALIES OR COMPLICATIONS WERE REPORTED DURING THE INITIAL PROCEDURE. ONE WEEK POSTOPERATIVELY, THE PATIENT PRESENTED TO THE USER FACILITY WITH A LOCALIZED INFECTION AT THE ACCESS SITE. THE PATIENT WAS SUBSEQUENTLY PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525134 CARDIVA MEDICAL INC. VASCADE MVP VCS VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention