BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11404111 · Received March 3, 2021

    Report

    Report Number
    3004742232-2021-00067
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    February 15, 2021
    Report Date
    April 20, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005794
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION CONCLUSION: THE OAD WAS RECEIVED AT CSI FOR ANALYSIS. THE DRIVESHAFT HAD BEEN DESTRUCTIVELY CUT. A COMPLETE ANALYSIS WAS NOT POSSIBLE DUE TO THE CONDITION OF THE RETURNED DEVICE. THE DRIVESHAFT SECTION WAS KEPT AT THE USER FACILITY FOR THEIR OWN ANALYSIS. AT THE CONCLUSION OF THE DEVICE ANALYSIS INVESTIGATION, THE REPORT THAT THE OAD BECAME STUCK IN THE VESSEL COULD NOT BE CONFIRMED THROUGH ANALYSIS. THE REPORTED DISSECTION ALSO 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. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 1

    RETURN OF THE DEVICE FOR ANALYSIS IS ANTICIPATED. IF THE DEVICE IS RECEIVED FOR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK DURING THE USE OF GLIDEASSIST TO ADVANCE THE OAD FOR TREATMENT OF CHRONIC TOTAL OCCLUSION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE USER INITIATED A LOW SPEED TREATMENT IN ORDER TO REMOVE THE OAD. A TYPE C DISSECTION OCCURRED IN THE LAD. ATHERECTOMY WAS STOPPED, AND THE PROCEDURE WAS COMPLETED WITH PLANNED STENT PLACEMENT. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301503 DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 342967 10852528005794

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other