BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL, INC VASCADE MVP

    MDR report key: 11756944 · Received April 30, 2021

    Report

    Report Number
    3004182619-2021-00007
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 30, 2021
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. IT IS PROBABLE THAT THE IRRITATION OCCURRED POST PROCEDURE THROUGH SITE CARE OR BECAUSE THE DEVICE WAS UTILIZED IN A SHALLOW TISSUE TRACT, BUT THIS CANNOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    DEPLOYED SUCCESSFULLY WITHOUT ISSUE. ON (B)(6) 2021 PATIENT RETURNED WITH REDNESS AND SWELLING AT THE ACCESS SITE. A CULTURE DETERMINED IT WAS A STAPHYLOCOCCUS INFECTION. ANTIBIOTICS WERE GIVING BUT DID NOT HAVE AN EFFECT. THE SURGEON OPENED THE ACCESS SITE DRAINED THE AREA AND THE WOUND WAS PACKED. PATIENT WAS ADMITTED FOR 5 DAYS BUT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648037 CARDIVA MEDICAL, INC VASCADE MVP VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C G612C210210B

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R