BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 4852797 · Received June 18, 2015

    Report

    Report Number
    3004742232-2015-00040
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 17, 2015
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE OAD WAS RECEIVED WITHOUT THE ORIGINAL GUIDEWIRE. THE INITIAL VISUAL EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND DRIVESHAFT REVEALED TWO KINKS IN THE DRIVESHAFT 14.3CM AND 32.2CM DISTAL TO THE ADAPTOR HYPOTUBE LAP WELD. FURTHER EXAMINATION OF THE CROWN AND DISTAL TIP BUSHING REVEALED THAT THEY REMAINED INTACT AND UNDAMAGED. NO BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT AND CROWN. THE OUTSIDE DIAMETER (OD) OF THE CROWN AND CROWN LOCATION ON THE DRIVESHAFT WERE MEASURED AND MET THE DRAWING SPECIFICATIONS. THE DRIVESHAFT WAS CUT JUST PROXIMAL TO THE DAMAGE TO ALLOW FURTHER TESTING. AN IN-HOUSE .014" TEST WIRE WAS LOADED THROUGH THE DEVICE WITHOUT ISSUE. WHEN TESTED, THE DEVICE SPUN AT LOW, MEDIUM AND AT HIGH SPEED WITH NO ABNORMALITIES OBSERVED. THE DEVICE WAS TURNED ON AND OFF NUMEROUS TIMES WITH NO ISSUES OBSERVED. WHILE PERFORMING FUNCTIONAL TESTING THE POWER CORD, BRAKE AND CONTROL KNOB WERE MANUALLY MANIPULATED TO DETERMINE IF THERE WERE ANY FUNCTIONAL CONCERNS WITH THE COMPONENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE AND COMPONENTS FUNCTIONED AS INTENDED WITH NO ABNORMALITIES OBSERVED. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION, THE ROOT CAUSE OF THE CLOT COULD NOT BE DETERMINED. THERE WAS NO DAMAGE OBSERVED WITH THE OAD THAT WOULD HAVE CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A CLOT BECAME PRESENT WHEN A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED INTO THE PATIENT. THE TARGET LESION WAS LOCATED IN THE TIBIOPERONEAL ARTERIAL TRUNK (TPT). THE PHYSICIAN ADVANCED A CSI VIPERWIRE GUIDEWIRE INTO THE PATIENT AND LOADED A CSI OAD ONTO THE GUIDEWIRE. WHEN THE PHYSICIAN TOOK A PRE-TREATMENT ANGIOGRAM, HE NOTED A CLOT PRESENT IN THE POPLITEAL ARTERY. THE OAD WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO ASPIRATE THE CLOT FROM THE PATIENT, BUT WAS UNSUCCESSFUL. THE PHYSICIAN ADMINISTERED TISSUE PLASMINOGEN ACTIVATOR (TPA) AND FOLLOWED-UP THAT UP WITH BALLOON ANGIOPLASTY TO RESOLVE THE CLOT. FURTHER INTERVENTION WAS ABORTED AND THE PHYSICIAN PLANNED TO BRING THE PATIENT BACK FOR ADDITIONAL TREATMENT AT A LATER DATE. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THREE REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, BUT NONE HAS YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397058 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INCORPORATED PRD-SC30-125 120020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention