BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP VCS

    MDR report key: 19705651 · Received July 9, 2024

    Report

    Report Number
    3004182619-2024-00018
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VASCADE MVP WAS NOT RETURNED FOR EVALUATION AS THE SINGLE DEVICE WAS DISCARDED BY THE USER FACILITY. NO FURTHER INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT REQUIRED VASCULAR SURGERY DUE TO AN ARTERIAL COMPLICATION POST AN ELECTROPHYSIOLOGICAL STUDY (EP) PROCEDURE. THE PHYSICIAN REPORTED THAT COLLAGEN WAS FOUND INSIDE THE INTRAVASCULAR VESSEL OF THE PATIENT'S VEIN FROM A PREVIOUS PROCEDURE. THE COLLAGEN WAS REMOVED AND DISCARDED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258440 CARDIVA MEDICAL INC. VASCADE MVP VCS VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown