BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11269515 · Received February 2, 2021

    Report

    Report Number
    3004742232-2021-00028
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Date of Event
    January 7, 2021
    Report Date
    February 25, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED OAD WAS RECEIVED FOR ANALYSIS. THE OAD WAS FRACTURED AT THE PROXIMAL EDGE OF THE CROWN. THE OAD FRAGMENT AND THE REST OF THE OAD DRIVESHAFT AND HANDLE WERE ENGAGED ON A GUIDE WIRE. THERE WAS NO DAMAGE OBSERVED ON THE GUIDE WIRE. THE FRACTURED OAD DRIVESHAFT SECTIONS WERE ANALYZED WITH SCANNING ELECTRON MICROSCOPY (SEM). SEM ANALYSIS IDENTIFIED FATIGUE STRIATIONS AT THE SITE OF THE FRACTURE. IT IS HYPOTHESIZED THAT THIS DRIVESHAFT UNDERWENT EXCESSIVE FLEXING NEAR THE CROWN DUE TO SPINNING IN EXCESSIVE TORTUOSITY OR RESISTANCE THAT PUSHED THE DRIVESHAFT INTO A TIGHT BEND SHAPE, ALTHOUGH THE EXACT ROOT CAUSE OF THIS REPORTED COMPLAINT IS UNDETERMINED. THE CORONARY OAS INSTRUCTIONS FOR USE STATES, "NEVER FORCE THE CROWN IF ANY RESISTANCE IS FELT WITHIN THE VESSEL AS VESSEL PERFORATION MAY OCCUR. IF RESISTANCE IS FELT, RETRACT THE CROWN, WHILE MONITORING THE CAUSE OF THE RESISTANCE, AND IMMEDIATELY STOP TREATMENT. USE FLUOROSCOPY TO ANALYZE THE SITUATION AND TO MONITOR THE CAUSE OF THE RESISTANCE." AT THE CONCLUSION 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. CSI ID# (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE REPORTED DEVICE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. CSI ID# (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK CORONARY PLUTO ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF AN 80% STENOSED, TYPE C LESION IN THE MID-LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE VESSEL HAD A DIAMETER OF 3.0MM AND WAS SEVERELY TORTUOUS. THE OAD WAS ADVANCED PAST THE LESION USING GLIDEASSIST MODE. THE TORTUOUS PART OF THE LESION WAS TREATED DISTAL TO PROXIMAL ON LOW SPEED. AFTER THE SECOND RUN, IT WAS NOTED THE DRIVESHAFT ON THE DISTAL EDGE OF THE CROWN WAS FRACTURED. THE FRAGMENT WAS REMOVED TOGETHER WITH THE OAD AND WIRE WITH NO ISSUE. THERE WAS NO PATIENT ADVERSE EVENT REPORTED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT WAS SCHEDULED FOR A SURGICAL CONSULT FOR A BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164292 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 340326-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR