BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11733198 · Received April 27, 2021

    Report

    Report Number
    3004742232-2021-00151
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 27, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OAD AND GUIDE WIRE WERE RECEIVED AT CSI FOR ANALYSIS. THE OAD WAS FRACTURED AND THE FRACTURED PORTION WAS ENGAGED ON THE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED WITH SOME RESISTANCE FROM THE FRACTURED DRIVESHAFT, AND THE GUIDE WIRE WAS OBSERVED TO BE KINKED AT THE LOCATION WHERE THE FRACTURE OCCURRED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS WAS PERFORMED, AND EVIDENCE OF FATIGUE WAS OBSERVED ON THE DRIVESHAFT FRACTURE FACES. ALTHOUGH THE ROOT CAUSE OF THE FRACTURE IS NOT CONFIRMED, THE DAMAGE WAS CONSISTENT WITH LOCALIZED, ELEVATED STRESS LEVELS APPLIED TO THE DRIVESHAFT WHILE SPINNING OVER THE GUIDE WIRE KINK. A GUIDE WIRE PASSED THROUGH THE REMAINING OAD DRIVESHAFT AND HANDLE ASSEMBLY WITH NO ISSUE. WHEN TESTED, THE OAD SPUN ON ALL SPEEDS AND FUNCTIONED AS INTENDED. AT THE END OF THE DEVICE ANALYSIS, THE REPORTED EVENT OF A DRIVESHAFT FRACTURE WAS CONFIRMED. 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. THE MATERIAL INSPECTION REPORT FOR THE REPORTED GUIDE WIRE COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. CSI ID# (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK GEN2 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A 99% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE INTIMA OF THE VESSEL WAS REPORTEDLY FILLED WITH 2MM THICK CALCIUM. IT WAS VERY DIFFICULT TO ADVANCE DEVICES THROUGH THE LESION. TWELVE TREATMENTS WERE PERFORMED FOR A TOTAL OF 154 SECONDS OF TREATMENT TIME. AFTER ATHERECTOMY WAS COMPLETED, IT WAS OBSERVED THAT THE OAD DRIVESHAFT WAS FRACTURED PROXIMAL TO THE CROWN. THE OAD, GUIDE WIRE, AND DRIVESHAFT FRAGMENT WERE RETRIEVED TOGETHER WITH THE DRIVESHAFT FRAGMENT REMAINING ON THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629353 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 364815-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR