BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 12796578 · Received November 11, 2021

    Report

    Report Number
    3004182619-2021-00020
    Event Type
    Injury
    Date Received
    November 11, 2021
    Date of Event
    October 8, 2021
    Report Date
    November 11, 2021
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNABLE TO BE INVESTIGATED BECAUSE IT WAS NOT RETURNED TO CARDIVA MEDICAL, INC. CONCLUSION: THE REPORTED EVENT IS NOT RELATED TO A DEVICE MALFUNCTION AND THE DEVICE WORKED AS INTENDED. IT IS POSSIBLE THAT THE RETROPERITONEAL BLEED WAS RELATED TO A HIGH STICK, BUT IMAGES WERE NOT PROVIDED TO CARDIVA MEDICAL, INC. A COMPLICATION SUCH AS RETROPERITONEAL BLEEDING 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 VASCADE 6/7F DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE 6F 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 THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN.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, AND THE DEVICE WAS REMOVED. PATIENT WAS MOVED TO RECOVERY. ONCE IN RECOVERY, THE PATIENT COMPLAINED OF PAIN AND THE PATIENT'S BLOOD PRESSURE DROPPED. IT WAS DETERMINED THAT THE PATIENT HAD A RETROPERITONEAL BLEED AND IT REQUIRED RETURNING TO SURGERY AND THE PLACEMENT OF A STENT. NO FURTHER INJURY OR COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690512 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I G580I210706A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention