BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIVA MEDICAL, INC VASCADE 5F

    MDR report key: 12351417 · Received August 20, 2021

    Report

    Report Number
    3004182619-2021-00016
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 20, 2021
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. FLUOROSCOPY OF THE DISC POSITION BEFORE COLLAGEN DEPLOYMENT WAS NOT OBTAINED, AND THE IMAGES WERE NOT PROVIDED TO CARDIVA MEDICAL INC. IT SHOULD BE NOTED THAT IMAGING IS SPECIFIED IN THE IFU TO LOCATE THE DISC POSITION AND ARTERIOTOMY LOCATION. IMAGING ALSO ALLOWS THE USER TO ASSESS THE SEVERITY OF THE VASCULAR DISEASE, VESSEL TORTUOSITY, AND VESSEL DIAMETER AND IDENTIFY THE PRESENCE OF AN EXISTING STENT OR OTHER IMPLANT AT THE ARTERIOTOMY SITE. THE DEVICE WAS NOT RETURNED, AND IMAGES OF THE SHEATH AND FLUOROSCOPY OF THE DEVICE PLACEMENT WERE NOT OBTAINED. NO DEVICE MALFUNCTION WAS REPORTED. CONCLUSION: FLUOROSCOPY WAS NOT UTILIZED TO VERIFY DISC PLACEMENT; THEREFORE, IT CANNOT BE DETERMINED IF THE DISC WAS PROPERLY PLACED FOR DEPLOYMENT. ADDITIONAL PROCEDURAL FACTORS SUCH AS SHEATH EXCHANGE, INSERTION OF CLOSURE DEVICE IN CONJUNCTION WITH THE DEGREE OF THE VASCULAR DISEASE AND CONDITION (CALCIFICATION NEAR THE ARTERIOTOMY SITE), AND INSUFFICIENT HYDRATION TIME OF THE COLLAGEN MAY HAVE BEEN CONTRIBUTING FACTORS TO THIS EVENT BUT THIS IS UNKNOWN.

    Description of Event or Problem · 1

    THE VASCADE 5F DEVICE WAS SELECTED FOR CLOSURE AND INSERTED INTO THE SHEATH. THE DISC WAS DEPLOYED, THE SHEATH WAS REMOVED, AND TEMPORARY HEMOSTASIS WAS ACHIEVED. IT SHOULD BE NOTED THAT THE USER DID NOT VERIFY DISC PLACEMENT BY UTILIZING FLUOROSCOPY BEFORE THE COLLAGEN WAS EXPOSED. THE KEY WAS INSERTED INTO THE LOCK/GRIP AND THE BLACK SLEEVE WAS RETRACTED TO EXPOSE THE COLLAGEN. THE COLLAGEN WAS STRIPPED OFF THE DEVICE AND THE DEVICE WAS REMOVED, BUT THE ACCESS SITE WAS STILL BLEEDING. THE STAFF CONVERTED TO MANUAL COMPRESSION TO ACHIEVE FINAL HEMOSTASIS ON THE ACCESS SITE. AT THIS POINT, IT WAS DETERMINED THAT THE PATIENT HAD A DIMINISHED PULSE IN THE LEG WHICH HAD THE ACCESS SITE, AND IT WAS DETERMINED THAT THE COLLAGEN HAD BEEN DEPLOYED IN THE ARTERY. THE USER USED A PENUMBRA DEVICE TO RETRIEVE THE COLLAGEN. NO OTHER INJURY OR COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243647 CARDIVA MEDICAL, INC VASCADE 5F VASCADE 5F MGB CARDIVA MEDICAL, INC. 700-500DX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention