BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 7131423 · Received December 19, 2017

    Report

    Report Number
    3004742232-2017-00156
    Event Type
    Death
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    December 19, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005169
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE OAD AND GUIDE WIRE WERE RECEIVED FOR ANALYSIS. THE DRIVESHAFT WAS FOUND TO BE FRACTURED AT THE DISTAL EDGE OF THE CROWN. THE GUIDE WIRE SPRING TIP PROXIMAL COILS AND ADHESIVE BOND WERE ALSO FOUND TO BE DAMAGED. THE FRACTURED DRIVESHAFT SECTION WAS SENT FOR SCANNING ELECTRON MICROSCOPY (SEM), WHICH FOUND EVIDENCE OF FATIGUE STRIATIONS ON THE FRACTURED DRIVESHAFT FILARS. THE OAD WAS TESTED USING AN IN HOUSE GUIDE WIRE AND SALINE PUMP, AND FUNCTIONED AS INTENDED WITH NO ABNORMALITIES NOTED. 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. AT THE CONCLUSION OF THE DEVICE ANALYSIS INVESTIGATION, THE REPORTED EVENT WAS CONFIRMED. HOWEVER, THE ROOT CAUSE OF THE DRIVESHAFT FRACTURE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP OF THE DEVICE BECAME DETACHED AND THE PATIENT LATER EXPIRED. THE TARGET LESION WAS 95% STENOSED AND LOCATED IN THE PROXIMAL CIRCUMFLEX. THE LESION WAS DIFFICULT TO CROSS, AND WAS TREATED WITH FIVE PASSES USING THE OAD. WHEN THE DEVICE WAS REMOVED, IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE TIP OF THE DEVICE HAD BECOME DETACHED. THE GUIDE WIRE WAS REMOVED WITH THE DEVICE FRAGMENT ATTACHED. BALLOON ANGIOPLASTY WAS ATTEMPTED, BUT THE BALLOON WOULD NOT CROSS THE LESION. A STENT WAS PLACED AND THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT STATUS DECLINED AND A VENTRICULAR ASSIST DEVICE WAS INSERTED, HOWEVER IT WAS REPORTED THAT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907415 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 185028 10852528005169

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death