BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 6940275 · Received October 11, 2017

    Report

    Report Number
    3004742232-2017-00101
    Event Type
    Death
    Date Received
    October 11, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 11, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005169
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE OAD WAS RETURNED WITHOUT THE ORIGINAL GUIDE WIRE. THE 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. FURTHER EXAMINATION REVEALED THAT THE CROWN AND DISTAL TIP BUSHING REMAINED INTACT AND UNDAMAGED. NO BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT OR CROWN. AN IN HOUSE .012" TEST WIRE WAS LOADED INTO THE DEVICE AND PASSED THROUGH WITHOUT RESISTANCE. WHEN TESTED, THE DEVICE SPUN AT LOW AND HIGH SPEED WITH NO ABNORMALITIES OBSERVED. NO DAMAGE WAS OBSERVED WITH THE DEVICE THAT WOULD HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. 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 WAS WITHIN SPECIFICATION AND PERFORMED AS INTENDED. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION, THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. 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 CORONARY ORBITAL ATHERECTOMY PROCEDURE, A POSSIBLE DISSECTION AND ADDITIONAL PATIENT COMPLICATIONS OCCURRED. THERE WERE TARGET LESIONS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND IN THE CIRCUMFLEX ARTERY. THE PHYSICIAN ACCESSED THE LESION USING A 7FR INTRODUCER SHEATH, AL1 GUIDE WIRE AND A RUNTHROUGH GUIDE WIRE. THE RUNTHROUGH GUIDE WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND A CSI ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED MULTIPLE RUNS AT LOW SPEED TO TREAT THE LESION IN THE LAD ARTERY. THE PHYSICIAN REMOVED THE OAD AND FOLLOWED-UP WITH BALLOON ANGIOPLASTY. AT THAT POINT, THE PHYSICIAN RE-ADVANCED THE CSI GUIDE WIRE INTO THE CIRCUMFLEX ARTERY AND LOADED THE OAD ONTO IT. THE PHYSICIAN AGAIN PERFORMED MULTIPLE RUNS AT LOW SPEED, BUT WAS UNABLE TO ADVANCE TO THE DISTAL SEGMENT OF THE LESION IN THE CIRCUMFLEX. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE, BUT WAS UNABLE TO DO SO AND HAD TO SPIN THE DEVICE PROXIMALLY. THE OAD WAS REMOVED FROM THE PATIENT, BUT ANGIOGRAPHY REVEALED SIGNIFICANT DISRUPTION IN THE PROXIMAL CIRCUMFLEX WITH A POSSIBLE DISSECTION. THE PATIENT BECAME PROGRESSIVELY HYPOTENSIVE AND BRADYCARDIC. EMERGENCY MEASURES WERE TAKEN AND THE PATIENT WAS INTUBATED, BUT WAS UNABLE TO RECOVER AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722125 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 196140 10852528005169

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death