BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL, INC. VASCADE 6/7F VCS

    MDR report key: 9775959 · Received March 2, 2020

    Report

    Report Number
    3004182619-2020-00005
    Event Type
    Death
    Date Received
    March 2, 2020
    Date of Event
    January 31, 2020
    Report Date
    March 2, 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

    CONCLUSION: A COMPLICATIONS SUCH AS RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE. THE DEVICE WORKED AS INTENDED. BASED ON THE IMAGING PRESENTED, IT APPEARS THE RETROPERITONEAL BLEED WAS THE RESULT OF ACCESS SITE ISSUE (HIGH STICK OF PROCEDURE SHEATHS IS A COMPLICATION OF ENDOVASCULAR PROCEDURES NOT RELATED TO THE CLOSURE DEVICE) AND NOT DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE VASCADE DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE 7FR SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. THE COLLAGEN WAS STRIPPED OFF THE DEVICE AND THE DEVICE WAS REMOVED. FINAL HEMOSTASIS ACHIEVED WITH THE DEVICE. UPON EXITING THE PROCEDURE ROOM, THE NURSE NOTICED TENDERNESS IN RIGHT GROIN AREA. UPON ARRIVE IN RECOVERY, THE PATIENTS BP DROPPED TO 70. A CT SCAN WAS PERFORMED WERE A RETROPERITONEAL BLEED WAS NOTED. PATIENT RETURNED TO PROCEDURE ROOM FOR SURGERY TO REPAIR THE RETROPERITONEAL BLEED. IN ADDITION, PATIENT RECEIVED A BLOOD TRANSFUSION. AFTER PROCEDURE, PATIENT RETURNED TO RECOVER AND CODED. RESUSCITATION FAILED AND PATIENT EXPIRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238682 CARDIVA MEDICAL, INC. VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death