BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL INC. VASCADE 6/7F VCS

    MDR report key: 9286120 · Received November 6, 2019

    Report

    Report Number
    3004182619-2019-00019
    Event Type
    Death
    Date Received
    November 6, 2019
    Date of Event
    August 28, 2019
    Report Date
    November 6, 2019
    Manufacturer
    CARDIVA MEDICAL, INC
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT RELATED TO DEVICE MALFUNCTION. A COMPLICATIONS SUCH AS RETROPERITONEAL BLEEDING ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE. THE DEVICE WORKED AS INTENDED. RETROPERITONEAL BLEEDS ARE 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

    AFTER MULTIPLE ATTEMPTS TO GAIN ACCESS, ULTRASOUND AND FLUOROSCOPY GUIDANCE WERE UTILIZED TO OBTAIN ACCESS IN THE RIGHT GROIN. POST PROCEDURE, THE VASCADE 6/7F WAS SELECTED FOR CLOSURE AND INSERTED INTO A 6FR PINNACLE SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE KEY WAS INSERTED INTO THE LOCK/GRIP, THE BLACK SLEEVE WAS RETRACTED, AND THE COLLAGEN WAS EXPOSED. THE COLLAGEN WAS STRIPPED OFF THE DEVICE, THE DISC WAS DE-DEPLOYED AND THE DEVICE WAS REMOVED. FINAL HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. THE SITE WAS BANDAGED AND PATIENT MOVED TO RECOVERY. DURING RECOVERY THE PATIENT WAS REPORTEDLY HYPOTENSIVE AND HAD A POSSIBLE VASOVAGAL RESPONSE. AT UNKNOWN TIME LATER, THE PATIENT BECAME UNSTABLE AND CODED. PATIENT THEN EXPIRED. PATIENT WAS DIAGNOSED WITH A RETROPERITONEAL BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080599 CARDIVA MEDICAL INC. VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death