BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1648231 · Received March 31, 2010

    Report

    Report Number
    3004742232-2010-00005
    Event Type
    Death
    Date Received
    March 31, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE OAD WAS RECEIVED WITH THE ORIGINAL CABLE ASSEMBLY AND GUIDE WIRE ENGAGED IN THE DEVICE. INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND DRIVESHAFT DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT; THE CROWN AND DISTAL TIP BUSHING WERE INTACT AND UNDAMAGED. AN IN-HOUSE UNDAMAGED .014" GUIDE WIRE WAS LOADED INTO THE OAD AND TESTED FOR FUNCTIONALITY. WHEN TESTED THE DEVICE SPUN AND REGISTERED RPMS IN THE TEST MODE. THE DEVICE HISTORY RECORD FOR THIS DEVICE HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, THE PATIENT'S CARDIAC RHYTHM CONVERTED TO ASYSTOLE AND HE EXPIRED. THE DIAMONDBACK INTERVENTION WAS INITIATED WITH A DB-SC30-150 CROWN WHICH WAS SPUN TO A MAX SPEED OF 200K RPMS IN THE COMMON FEMORAL/SFA LESION FOR A TOTAL RUN TIME OF 2 MINUTES, 43 SECONDS. AT THIS TIME, THE PATIENT COMPLAINED OF DIFFICULTY BREATHING, SO THE INTERVENTION WAS CEASED. WITHIN A SHORT TIME, THE PATIENT'S SYMPTOMS RESOLVED. BECAUSE HE WAS NOT A CANDIDATE FOR SURGERY, THE PHYSICIAN ATTEMPTED TO IMPROVE THE STATUS OF THE VESSEL BY CONTINUING INTERVENTION WITH A DB-SC30-200 CROWN. AFTER SANDING TO A MAX SPEED OF 160K RPMS FOR A TOTAL RUN TIME OF 1 MINUTE, 03 SECONDS, THE PATIENT'S CARDIAC RHYTHM CONVERTED TO ASYSTOLE AND HE EXPIRED. THERE HAD BEEN NO SIGNS OF A DISSECTION, NO PERFORATION, NO SLOW FLOW, NO ABRUPT CLOSURE, NO SPASM, AND NO PAIN DURING THE INTERVENTION. THREE WRITTEN REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. DB-SC30-200 28975

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death