BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11112822 · Received January 4, 2021

    Report

    Report Number
    3004742232-2021-00001
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    December 8, 2020
    Report Date
    January 11, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED OAD WAS RECEIVED FOR ANALYSIS. ADHERED FIBROUS AND BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT AND CROWN. EXAMINATION IN THE AREA DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE ACCUMULATION. THE MORPHOLOGY AND EXACT ROOT CAUSE OF THE ACCUMULATION IS UNKNOWN. A GUIDE WIRE PASSED THROUGH THE DEVICE, INCLUDING THE AREA OF ACCUMULATION, WITHOUT ISSUE. THE OAD WAS TESTED AND FUNCTIONED AS INTENDED. AT THE CONCLUSION OF THE DEVICE ANALYSIS, THE REPORTED EVENT OF A PERFORATION WAS UNABLE TO BE CONCLUSIVELY CONFIRMED. IT IS POSSIBLE THE ADHERED MATERIAL MAY HAVE CONTRIBUTED TO THE EVENT; HOWEVER, THIS COULD NOT BE 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. H10: RESULTS CODE: 4247 - SUGGESTED CODE IS BIOLOGICAL MATERIAL PRESENT ON DEVICE INVESTIGATION CONCLUSIONS CODE 22: THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE INSTRUCTIONS FOR USE STATES THAT PERFORATION IS A POSSIBLE ADVERSE EVENT WHICH CAN OCCUR WITH USE OF THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE. 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 ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE CIRCUMFLEX LESION WAS TREATED SUCCESSFULLY, AND THE OAD WAS ADVANCED TO THE PROXIMAL LAD USING GLIDEASSIST MODE. THE LAD WAS APPROXIMATELY 3.1MM IN DIAMETER AND MILDLY TORTUOUS. THE 75-80% STENOSED, SEVERELY CALCIFIED LESION WAS TREATED WITH SEVERAL PASSES ON LOW SPEED, AND THE OAD WAS RETRACTED TO THE GUIDE CATHETER USING GLIDEASSIST MODE. THE PATIENT COMPLAINED OF CHEST PAIN. ANGIOGRAPHY SHOWED A PROXIMAL LAD PERFORATION. THE PERFORATION WAS DILATED WITH BALLOON ANGIOPLASTY, AND A STENT WAS PLACED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND DISCHARGED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7182 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 334476-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R