BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL VASCADE 6/7F VCD

    MDR report key: 16646676 · Received March 30, 2023

    Report

    Report Number
    3004182619-2023-00006
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    March 6, 2023
    Report Date
    March 30, 2023
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS UNABLE TO BE INVESTIGATED BECAUSE IT WAS NOT RETURNED TO CARDIVA MEDICAL INC. CONCLUSION: WHILE THE DEVICE WAS NOT RETURNED FOR PHYSICAL INVESTIGATION. PSEUDOANEURYSM ARE COMPLICATIONS WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE. SURGERY WAS SUCCESSFULLY APPLIED POST PROCEDURE TO REPAIR THE PSEUDOANEURYSM. THE REPORTED ISSUES WERE NOT RELATED TO DEVICE MALFUNCTION, BUT WAS THE RESULT OF AN ENDOVASCULAR PROCEDURE.

    Description of Event or Problem · 0

    THE VASCADE 6/7F DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE 6F 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 THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. AT THIS POINT, THE USER OBSERVED THAT HE LOST TEMPORARY HEMOSTASIS AND PULLED THE DEVICE BACK APPROXIMATELY 1 CM AND ACHIEVED TEMPORARY HEMOSTASIS. THE USER HELD FOR 1 MINUTE AND THEN UTILIZED THE PUSH ROD TO STRIP THE COLLAGEN FROM THE DEVICE, AND THE DEVICE WAS REMOVED. PATIENT WAS MOVED TO RECOVERY WHERE A PSEUDOANEURYSM WAS LOCATED AND REQUIRED SURGERY TO CORRECT. NO OTHER COMPLICATIONS OR INJURIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211340 CARDIVA MEDICAL VASCADE 6/7F VCD VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention