BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOOMERANG CATALYST II SYSTEM

    MDR report key: 1397316 · Received May 29, 2009

    Report

    Report Number
    3004182619-2009-00004
    Event Type
    Death
    Date Received
    May 29, 2009
    Date of Event
    April 29, 2009
    Report Date
    May 1, 2009
    Manufacturer
    CARDIVA MEDICAL, INC.
    Product Code
    DXC
    PMA / PMN Number
    K072297
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE INCIDENT WAS REPORTED TO THE CARDIVA MEDICAL SALES REPRESENTATIVE, HE WAS TOLD BY STAFF MEMBERS PRESENT DURING THE PROCEDURE THAT THE PHYSICIAN PERFORMED A "HIGH STICK" ON THE PATIENT. THIS TERM IS USED WHEN THE PHYSICIAN ACCESSES THE FEMORAL ARTERY ABOVE THE INGUINAL LIGAMENT. THE INSTRUCTIONS FOR USE FOR THE CATALYST II CONTAIN A CAUTION SECTION WHICH STATES: DO NOT USE IN ACCESS SITES ABOVE THE INGUINAL LIGAMENT (SUPRA-INGUINAL PUNCTURES) DUE TO THE INCREASED RISK OF RETROPERITONEAL BLEEDING. IN A FOLLOW-UP CONVERSATION BETWEEN THE CARDIVAL MEDICAL SALES REPRESENTATIVE AND A REPRESENTATIVE OF THE HOSPITAL, CARDIVA WAS INFORMED THAT THE HOSPITAL IS STILL IN THE PROCESS OF PERFORMING RISK ASSESSMENT AND EVALUATION OF THE INCIDENT, AND WOULD PROVIDE CARDIVA MEDICAL WITH MORE INFORMATION UPON COMPLETION OF THAT ASSESSMENT. CARDIVA WAS ALSO INFORMED THAT THE DEVICE INVOLVED IN THE INCIDENT HAD BEEN DISCARDED AND WOULD NOT BE SENT BACK TO CARDIVA FOR INVESTIGATION. AS THE LOT NUMBER OF THE DEVICE IS ALSO UNKNOWN, NO REVIEW CAN BE PERFORMED. UPON RECEIPT OF ANY FURTHER INFORMATION ON THIS INCIDENT, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A CARDIVA MEDICAL, INC SALES REPRESENTATIVE WAS INFORMED THAT A PATIENT EXPIRED IN 2009, WITH A CATALYST II DEPLOYED. THE PATIENT WAS MALE AND SLIGHTLY OVERWEIGHT. THE PROCEDURE INVOLVED A SINGLE STICK, PCI, USING A 6 FR SHEATH. THE DEVICE WAS DEPLOYED AND TEMPORARY HEMOSTASIS ACHIEVED UNEVENTFULLY. THE PATIENT DIED WITHIN 20 MINUTES OF THE CATALYST II DEPLOYMENT. THE HOSPITAL IS AWAITING AN AUTOPSY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOOMERANG CATALYST II SYSTEM VASCULAR CLAMP DXC CARDIVA MEDICAL, INC. 500-580C

    Patients

    Seq Age Sex Outcome Treatment
    1 Death