BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP VCS

    MDR report key: 9832773 · Received March 14, 2020

    Report

    Report Number
    3004182619-2020-00006
    Event Type
    Death
    Date Received
    March 14, 2020
    Date of Event
    February 14, 2020
    Report Date
    March 13, 2020
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INITIAL REPORT, THE VASCADE MVP DEVICE PERFORMED PER SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR PHYSICAL INVESTIGATION. THE COMPLAINT REPORTS AN INFECTION. THERE IS NO REPORT OF DEVICE MALFUNCTION AND ALL DEVICES ARE STERILIZED THROUGH VALIDATED METHOD AND STERILIZATION CERTIFICATE IS ON FILE FOR ALL LOTS OF DEVICES.

    Description of Event or Problem · 1

    THE PATIENT HAD 4 ACCESS SITES THAT ALL UTILIZED THE VASCADE MVP DEVICE FOR CLOSURE. ALL 4 OF THE DEPLOYMENTS WENT WELL AND FINAL HEMOSTASIS WAS ACHIEVED WITH THE VASCADE MVP DEVICES. ONE OF THE SITES DEVELOPED A 4 CM X 4 CM HEMATOMA WHICH WAS PRESSED OUT. THE NEXT DAY PATIENT DEVELOPED NECROTIZING FASCIITIS AND A FASCIOTOMY WAS PERFORMED. PATIENT BECAME SEPTIC. IT IS NOTED THAT PATIENT HAD A HISTORY OF PERIPHERAL VASCULAR DISEASE, BUT THE DOCTOR DID NOT HAVE ISSUE GAINING ACCESS TO THE VEINS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020: PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296205 CARDIVA MEDICAL INC. VASCADE MVP VCS VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death