BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIVA VASCADE 6/7F VCS

    MDR report key: 6598642 · Received May 30, 2017

    Report

    Report Number
    3004182619-2017-00013
    Event Type
    Death
    Date Received
    May 30, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 30, 2017
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    MGB
    PMA / PMN Number
    P120016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE REPORTED EVENT WAS NOT RELATED TO DEVICE MALFUNCTION AND NO DEVICE MALFUNCTION REPORTED. COMPLICATIONS SUCH AS HEMATOMA ARE GENERAL COMPLICATIONS WHICH MAY BE RELATED TO ENDOVASCULAR PROCEDURES OR VASCULAR CLOSURE. AS FOR BLEEDING, IT IS STATED IN THE IFU UNDER PRECAUTIONS "DO NOT USE IF ARTERIOTOMY IS NOTED TO BE A "SIDE STICK." BLEEDING RISK MAY INCREASE".

    Description of Event or Problem · 1

    ON (B)(6) 2017 THE DOCTOR INSERTED THE DEVICE INTO THE SHEATH, DEPLOYED THE DISC, TEMPORARY HEMOSTASIS WAS ACHIEVED, AND REMOVED THE SHEATH. THE KEY WAS INSERTED INTO THE LOCK AND THE BLACK SLEEVE WAS RETRACTED AND SOME ARTERIAL SPRAY WAS NOTED. THE DOCTOR DID NOT TAKE A FLUOROSCOPY TO VERIFY THE POSITION OF THE DISC. THE DOCTOR THEN STRIPPED THE COLLAGEN OFF THE WIRE AND REMOVED THE DEVICE. THERE WAS STILL BLOOD FLOW FROM THE ACCESS SITE AND THE STAFF HELD PRESSURE FOR 25-30 MINUTES. THE PATIENT WAS TRANSFERRED TO THE RECOVERY AREA WITHOUT MORE APPARENT BLEEDING AND A SANDBAG WAS PLACED ON HER GROIN. A REVIEW OF THE "GROIN SHOT" BY THE CARDIVA REPRESENTATIVE SHOWED THAT THE ACCESS SITE WAS A SIDEWALL STICK. AFTER THE REQUIRED BEDREST IN RECOVERY, THE PATIENT ATTEMPTED TO STAND A FEW TIMES BUT WOULD HAVE A VASOVAGAL RESPONSE. THEREFORE, THE PATIENT WAS ADMIT FOR OBSERVATION AND HAD A CT SCAN. THE CT SCAN DETERMINED THAT SHE DID NOT HAVE AN RETROPERITONEAL BLEED, BUT DID NOTE A HEMATOMA AT THE GROIN WHICH WAS PRESSED OUT. NO EVIDENCE OF ARTERIAL OCCLUSION NOTED. PULSE SEEMED CORRECT AND LEG NOT COLD. AFTER SHE WAS CLEARED OF HER RESULTS, SHE WAS DISCHARGED ON (B)(6) 2017. ON (B)(6) 2017 AFTER PATIENT WENT HOME, SHE ULTIMATELY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379605 CARDIVA VASCADE 6/7F VCS VASCADE 6/7F MGB CARDIVA MEDICAL, INC. 700-580I UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death