BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 5980233 · Received September 27, 2016

    Report

    Report Number
    3004182619-2016-00033
    Event Type
    Death
    Date Received
    September 27, 2016
    Date of Event
    June 24, 2016
    Report Date
    September 27, 2016
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE.

    Description of Event or Problem · 1

    ON, (B)(6) 2016, A FEMALE UNDERWENT A NORMAL HEART CATH WITHOUT INTERVENTION THROUGH THE RIGHT FEMORAL ARTERY. THE VASCADE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE KEY WAS INSERTED INTO THE LOCK AND THE COLLAGEN WAS EXPOSED AND DEPLOYED. FINAL HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. IT WAS NOTED NO HEMATOMA PRESENT AFTER DEPLOYMENT NOR ONCE HANDED OFF TO THE UNIT ON THE FLOOR. THERE WAS NORMAL BLOOD PRESSURE. IN POST OBSERVATION, THE PATIENT COMPLAINED OF BACK PAIN AND LATER HAD ACUTE HYPOTENSION RESULTED IN BLOOD TRANSFUSION, INTUBATION, AND RESUSCITATION. A RETROPERITONEAL BLEED WAS LOCATED. SHE LATER PASSED AWAY ON (B)(6) 2016 IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631924 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I G580I160516A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death