BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL INC. VASCADE MVP VCS

    MDR report key: 20075390 · Received August 27, 2024

    Report

    Report Number
    3004182619-2024-00019
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 24, 2024
    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
    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. A COMPLICATION SUCH AS RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME; IT IS NOT POSSIBLE TO DETERMINE IF THERE WAS A DEFECT RELATED TO THE MANUFACTURING OF THE DISPOSABLE DUE TO A DEFECT WAS NOT CONFIRMED/ NO SAMPLE PROVIDED FOR EVALUATION. THIS LOT WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE, WITH NO NOTED MANUFACTURING DEVIATIONS, NCE'S OR CAPAS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT AN ARTERIAL FLUTTER ABLATION PROCEDURE USING THE VASCADE MVP, WHICH WAS INSERTED INTO AN 11FR SHEATH. THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE THE PATIENT HAD BEEN ADMINISTERED 10000 UNITS OF HEPARIN AND HAVING DIFFICULTY CLOSING THE SHEATH SITE, LEADING TO SIGNIFICANT BLEEDING. DESPITE APPEARING FINE 1-HOUR POST-PROCEDURE, THE PATIENT BEGAN SATURATING THE GAUZE, REQUIRING ADDITIONAL PRESSURE AND 3-4 DRESSING CHANGES. DUE TO CONTINUOUS BLEEDING, THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. 24 HOURS POST-PROCEDURE, THE PHYSICIAN NOTED THAT THE COLLAGEN PLUG WAS STICKING HALFWAY OUT OF THE ACCESS SITE. THE COLLAGEN WAS REMOVED, AND FEM STOP WAS APPLIED. A VASCULAR SURGEON WAS CONSULTED AND DETERMINED THAT THIS WAS A VENOUS BLEED. THE SURGEON SUTURED THE VEIN AND USED ANOTHER DEVICE TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939901 CARDIVA MEDICAL INC. VASCADE MVP VCS VASCADE MVP MGB CARDIVA MEDICAL, INC. 800-612C G612C240515B

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention