BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 7500009 · Received May 9, 2018

    Report

    Report Number
    3004182619-2018-00012
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 9, 2018
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNABLE TO BE INVESTIGATED BECAUSE IT WAS NOT RETURNED TO CARDIVA MEDICAL INC. CONCLUSION: WHILE THE DEVICE WAS NOT RETURNED FOR PHYSICAL INVESTIGATION. PSUEDOANEURYSM IS A COMPLICATION WHICH MAY BE RELATED TO THE ENDOVASCULAR PROCEDURE OR THE VASCULAR CLOSURE PROCEDURE. SURGERY WAS SUCCESSFULLY APPLIED POST PROCEDURE TO REPAIR THE PSUEDOANEURYSM. THE REPORTED ISSUES WERE NOT RELATED TO DEVICE MALFUNCTION, BUT WAS THE RESULT OF AN ENDOVASCULAR PROCEDURE. THE UNABLE TO GAIN HEMOSTASIS COULD BE BIOLOGICAL FACTORS OR USE ERROR BUT THAT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT HAD SEVERE STENOSIS OF THE RIGHT COMMON FEMORAL ARTERY AS WELL AS AN OCCLUSION OF THE POPLITEAL ARTERY. THE VASCADE DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. THE DOCTOR REMOVED THE SHEATH, BUT THE DEVICE WAS REMOVED WITH THE SHEATH AND WITH THE DISC OPEN. THE STAFF REVERTED TO MANUAL COMPRESSION, TO ACHIEVED HEMOSTASIS. PRESSURE WAS HELD FOR 20 MINUTES IN THE PROCEDURE ROOM AND THEN AN HOUR IN THE RECOVERY ROOM. AT THIS POINT, THE STAFF OBSERVED A HEMATOMA FORMING AND A CT ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A PSEUDOANEURYSM. THE PATIENT WAS RETURNED TO THE PROCEDURE ROOM AND THE DOCTOR INSERTED A BALLOON INTO THE VESSEL TO TAMPONADE THE PSEUDOANEURYSM. THE PSEUDOANEURYSM WAS CORRECTED AND NO FURTHER COMPLICATION OR INJURY WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340572 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I G580I180129A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention