BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 6304236 · Received February 6, 2017

    Report

    Report Number
    3004182619-2017-00005
    Event Type
    Death
    Date Received
    February 6, 2017
    Date of Event
    December 15, 2016
    Report Date
    February 6, 2017
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED DEVICE ISSUE. CONCLUSION: THE REPORTED EVENT WAS NOT RELATED TO DEVICE MALFUNCTION. COMPLICATIONS SUCH AS HEMATOMA ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE.

    Description of Event or Problem · 1

    AFTER A CORONARY STENT WAS PLACED, THE VASCADE DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, TEMPORARY HEMOSTASIS WAS ACHIEVED AND THE SHEATH WAS REMOVED. THE KEY WAS INSERTED INTO THE LOCK, THE BLACK SLEEVE WAS RETRACTED AND THE COLLAGEN WAS EXPOSED. THE COLLAGEN WAS DEPLOYED AND THE DEVICE WAS REMOVED. FINAL HEMOSTASIS WAS ACHIEVED. THE VASCADE DEVICE WORKED AS INTENDED AND THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE PATIENT WAS TRANSFERRED TO RECOVER. AT RECOVER, A LARGE HEMATOMA WAS NOTICED AND PRESSURE WAS APPLIED. PATIENT WAS ALERT AND ORIENTED AT THIS TIME. CAT SCAN WAS PERFORMED AND RETROPERITONEAL BLEED WAS RULED OUT. BP WAS FLUCTUATING AND PATIENT BECAME UNRESPONSIVE. PATIENT WAS TRANSFERRED TO ICU AND PAST AWAY FROM CARDIAC ARREST 12 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87331 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I G580I161019A

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death