BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 5608532 · Received April 26, 2016

    Report

    Report Number
    3004182619-2016-00010
    Event Type
    Death
    Date Received
    April 26, 2016
    Date of Event
    January 20, 2016
    Report Date
    April 25, 2016
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AND LOT NUMBER UNKNOWN.

    Description of Event or Problem · 1

    THE VASCADE 6/7F DEVICE WAS SELECTED FOR CLOSURE. THE DEVICE WAS INSERTED INTO THE SHEATH AND DEPLOYED. THE SHEATH WAS REMOVED AND WHEN THE DOCTOR ATTEMPTED TO ACHIEVE TEMPORARY HEMOSTASIS THE DEVICE PULLED OUT OF THE ACCESS SITE. THE STAFF HELD MANUAL COMPRESSION TO ACHIEVE FINAL HEMOSTASIS. THE PATIENT WAS SENT TO DIALYSIS. THREE HOURS LATER THE ANGIO LAB WAS CONTACTED BY THE DIALYSIS LAB TO COME CHECK ON THE PATIENT. WHEN ANGIO STAFF ARRIVED THE PATIENT WAS IN FETAL POSITION AND HAD BEEN SITTING UP. PATIENT'S GROIN AREA LOOK OK BUT HIS TESTICLES WERE EXTREMELY SWOLLEN. PRESSURE WAS HELD AND THE DOCTOR WAS CALLED TO COME CHECK PATIENT. WHILE WAITING FOR THE DOCTOR, THE PATIENT CODED. CPR WAS DONE ON PATIENT AND HE RECOVERED AND WAS STABLE. PATIENT HAD A CT SCAN AND WENT TO SURGERY TO REPAIR COMMON FEMORAL ARTERY. PATIENT WENT BACK TO ANGIO THE NEXT DAY AND A CENTRAL LINE AND DIALYSIS CATHETER WERE PLACED. FOUR DAYS LATER THE PATIENT DIED. NO OTHER INFORMATION PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262254 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death