BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL VASCADE 6/7F VCS

    MDR report key: 21514317 · Received March 4, 2025

    Report

    Report Number
    3004182619-2025-00005
    Event Type
    Death
    Date Received
    March 4, 2025
    Date of Event
    January 24, 2025
    Report Date
    March 4, 2025
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE VASCADE 6/7F DEVICE WILL NOT BE RETURNED TO HAEMONETICS FOR EVALUATION; THEREFORE, NO PHYSICAL INVESTIGATION WILL BE CONDUCTED. AS PART OF OUR INVESTIGATION A REVIEW OF THE COMPLAINT WAS CONDUCTED AND FOUND THAT THE DEVICE WAS DEPLOYED SUCCESSFULLY AND THERE WAS NO REPORT OF ANY ANOMALIES WITH THE COLLAGEN DISK. TEMPORARY HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. HAEMONETICS FOLLOWED UP WITH THE ACCOUNT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND LEARNED THAT THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND HAD A HISTORY OF ANTICOAGULANT THERAPY. NO AUTOPSY WILL BE PERFORMED. A MEDICAL ASSESSMENT WAS CONDUCTED BY THE HAEMONETICS MEDICAL STAFF, AND IT WAS DETERMINED THAT THE VASCULAR CLOSURE PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COLLAGEN WAS SUCCESSFULLY DEPLOYED, ACHIEVING TEMPORARY HEMOSTASIS; HOWEVER, FINAL HEMOSTASIS WAS NOT ACHIEVED. IT WAS DETERMINED THAT WHILE THE MAJOR BLEEDING THAT NECESSITATED A BLOOD TRANSFUSION COULD POSSIBLY BE ASSOCIATED WITH THE SUBJECT VASCADE 6/7 DEVICE OR THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, PARTICULARLY REGARDING THE ANTICOAGULATION DOSAGE FOR THIS PATIENT. THE EXACT ROOT CAUSE OF THIS EVENT IS LIKELY MULTIFACTORIAL. IN ADDITION, THE VASCULAR CLOSURE SYSTEM (VASCADE VCS) INSTRUCTIONS FOR USE 5F AND 6/7 STATES THAT BOTH A HEMATOMA AND BLEEDING AT THE SITE ARE COMPLICATIONS THAT MAY OCCUR AND MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT A PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE USING THE VASCADE 6/7F DEVICE, WHICH WAS INSERTED INTO A 6F SHEATH. DURING THE PROCEDURE, THE PATIENT RECEIVED THE ANTICOAGULANT ANGIOMAX (BIVALIRUDIN), AND THERE WERE NO KNOWN ISSUES WITH THE DEVICE, AS THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AFTER THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO RECOVERY, WHERE A HEMATOMA WAS OBSERVED. WHILE MANUAL COMPRESSION WAS APPLIED, REBLEEDING OCCURRED AT THE ACCESS SITE. ATTEMPTS AT CONTINUED MANUAL COMPRESSION WERE UNSUCCESSFUL, LEADING TO THE USE OF A FEMOSTOP DEVICE. THE PATIENT REQUIRED A TRANSFUSION, RECEIVING FOUR LITERS OF BLOOD PRODUCTS, AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586387 CARDIVA MEDICAL VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death