BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA MEDICAL VASCADE 6/7F VCS

    MDR report key: 12927274 · Received December 3, 2021

    Report

    Report Number
    3004182619-2021-00021
    Event Type
    Death
    Date Received
    December 3, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 3, 2021
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE REPORTED EVENT IS NOT RELATED TO A DEVICE MALFUNCTION AND THE DEVICE WORKED AS INTENDED, WITH THE EXCEPTION OF THE USE ERROR OF NOT DE-DEPLOYING THE DISC BEFORE REMOVAL. (THIS WOULD NOT HAVE CAUSED THE REPORTED COMPLICATIONS.) IT IS POSSIBLE THAT THE RETROPERITONEAL BLEED WAS RELATED TO THE REPORTED BACKWALL STICK OR POSSIBLE A HIGH STICK, BUT IMAGES WERE NOT PROVIDED TO CARDIVA MEDICAL, INC. A COMPLICATION SUCH AS RETROPERITONEAL BLEEDING AND DEATH ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE. PER THE REPORT, HEMOSTASIS WAS ACHIEVED WITH THE DEVICE.

    Description of Event or Problem · 0

    THE PROCEDURE WAS TO INSTALL 3 STENTS. THE VASCADE 6/7F DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE 7F 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 THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. THE PUSH ROD WAS UTILIZED TO STRIP THE COLLAGEN FROM THE DEVICE. AT THIS POINT THE USER, NEGLECTED TO DE-DEPLOY THE DISC AND PULLED THE DEVICE THROUGH THE ACCESS SITE. THE COLLAGEN REMAINED IN PLACE AND FINAL HEMOSTASIS WAS ACHIEVED WITH THE DEVICE. THE PATIENT WAS MOVED TO RECOVERY. 15 MINUTES LATER IT WAS DETERMINED THAT PATIENT HAD A RETROPERITONEAL BLEED, THAT THE HOSPITAL BELIEVES TO BE A BACKWALL STICK. IT IS NOT KNOWN WHAT STEPS WERE USED TO ADDRESS THE RETROPERITONEAL BLEED. LATER THAT NIGHT PATIENT PASSED AWAY. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820077 CARDIVA MEDICAL VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death