BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 18874274 · Received March 11, 2024

    Report

    Report Number
    3004742232-2024-00124
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 8, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850026568698
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE OAD WAS RETURNED WITHOUT THE GUIDE WIRE. REVIEW OF THE DEVICE DATA LOG IDENTIFIED STALL EVENTS ON GLIDEASSIST MODE DURING THE PROCEDURE. THE CAUSE OF THE STALL EVENT WAS UNABLE TO BE DETERMINED. THE CROWN DIAMETER WAS MEASURED AND MET SPECIFICATION. WHEN TESTED, THE OAD FUNCTIONED AS INTENDED. 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).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 CORONARY PRECISION ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH GLIDEASSIST TO ADVANCE INTO A TORTUOUS, HEAVILY CALCIFIED, 85% STENOSED, 3.5 MM CIRCUMFLEX ARTERY (CX). THE OAD BECAME STUCK IN THE VESSEL AND GLIDEASSIST WAS ATTEMPTED TO BE USED TO RETRACT THE OAD. HOWEVER, THE OAD REPEATEDLY STALLED. DURING THIS EVENT, THE OAD LIGHTS REMAINED ILLUMINATED. A BUDDY WIRE AND GUIDE LINER WERE ADVANCED NEXT TO THE VIPERWIRE ADVANCE GUIDE WIRE AND OAD. THE PHYSICIAN USED A BALLOON NEXT TO THE OAD. THE OAD WAS ABLE TO BE SUCCESSFULLY REMOVED. THE OAD WAS THEN ADVANCED TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A PERFORATION WAS OBSERVED. IN THE PHYSICIAN'S OPINION, THE PERFORATION WAS CAUSED BY THE VIPERWIRE. THE DISTAL LAD WAS COILED TO TREAT THE PERFORATION. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465519 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 517201-1 10850026568698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention UNKNOWN CORONARY VIPERWIREUNKNOWN LOT NUMBER