BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL, INC VASCADE 6/7F VCS

    MDR report key: 12204540 · Received July 21, 2021

    Report

    Report Number
    3004182619-2021-00014
    Event Type
    Death
    Date Received
    July 21, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 21, 2021
    Manufacturer
    CARDIVA MEDICAL INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS NOT RETURNED, IT IS NOT POSSIBLE TO DETERMINE IF THE DEVICE PULLED THROUGH WHEN ATTEMPTING TO GAIN TEMPORARY HEMOSTASIS AS A RESULT OF A USER ERROR OR MANUFACTURING DEFECT. 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. THE REPORTED ISSUES OCCURRED POST DISCHARGE. SURGERY WAS SUCCESSFULLY APPLIED POST PROCEDURE TO REPAIR THE PSEUDOANEURYSM, BUT THE PATIENT PASSED AWAY 3 DAYS AFTER THE SURGERY. THE CAUSE OF THE DEATH HAS NOT BEEN PROVIDE TO CARDIVA MEDICAL, INC. IT WOULD BE EXTREMELY UNLIKELY SEQUENCE OF EVENTS FOR THE DEVICE PULLING THROUGH THE ACCESS SITE WHEN ATTEMPTING TO GAIN TEMPORARY HEMOSTASIS TO CAUSE THE HARM OF A PSEUDOANEURYSM OR DEATH.

    Description of Event or Problem · 1

    THE VASCADE 6/7F DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE 6FR SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, WHEN THE USER ATTEMPTED TO GAIN TEMPORARY HEMOSTASIS, THE DEVICE PULLED THROUGH THE ACCESS SITE. THE STAFF REVERTED TO MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PATIENT WAS THEN DISCHARGED. PATIENT RETURNED ON (B)(6) 2021, WITH COMPLAINT OF PAIN AND IT WAS DETERMINED THAT PATIENT HAD A PSEUDOANEURYSM WHICH REQUIRED SURGERY TO CORRECT. SURGERY SUCCESSFULLY CORRECTED THE ISSUE AND PATIENT WAS DISCHARGED. IT SHOULD BE NOTED THAT THE USER USED ULTRASOUND GUIDANCE BUT REQUIRED MULTIPLE ATTEMPTS TO GAIN ACCESS TO THE SITE. ADDITIONAL INFORMATION PROVIDED ON 7/13/21: ON (B)(6) 2021, PATIENT PASSED AWAY FROM UNKNOWN CAUSES. NO OTHER INFORMATION WAS PROVIDED AND USER DECLINE TO SPEAK WITH CARDIVA REPRESENTATIVE ABOUT THIS CASE. CARDIVA REPRESENTATIVES ATTEMPTED TO CONTACT THE USER ON 7/2/21, 7/13/21 AND ON 7/16/21 CONTACTED THE CATH LAB MANAGER. THE CATH LAB MANGER STATED THAT NO OTHER INFORMATION IS AVAILABLE BECAUSE THE PATIENT PASSED AWAY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104323 CARDIVA MEDICAL, INC VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL INC. 700-580I G580I210309A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R