BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 19710891 · Received July 10, 2024

    Report

    Report Number
    3004742232-2024-00255
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 22, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION H6: ADDITIONAL CODE ADDED 2687. UPDATED FIELDS: B4, D9, G3, H2, H3. THE VIPERWIRE ADVANCE GUIDEWIRE WAS RETURNED FOR ANALYSIS. THE OAD WAS NOT RETURNED FOR ANALYSIS. A FRACTURE WAS OBSERVED NEAR THE SPRING TIP OF THE GUIDE WIRE. SCANNING ELECTRON MICROSCOPIC (SEM) ANALYSIS IDENTIFIED EVIDENCE OF DUCTILE TENSILE FAILURE ON THE CORE WIRE FRACTURE FACE. THIS EVIDENCE IS CONSISTENT WITH THE DRIVESHAFT MAKING CONTACT WITH THE SPRING TIP LEADING TO THE FRACTURE. THE ROOT CAUSE OF THE EVENT WAS CONSIDERED TO BE USE NOT CONSISTENT WITH THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE (IFU). THE IFU STATES, "DO NOT COME WITHIN 5 MM OF THE PROXIMAL END OF THE VIPERWIRE GUIDE WIRE SPRING TIP WITH THE DISTAL END OF THE OAD DRIVE SHAFT. IF THE DISTANCE BETWEEN THE SHAFT TIP AND THE VIPERWIRE GUIDE WIRE SPRING TIP IS INSUFFICIENT, THE SHAFT TIP MAY CONTACT THE GUIDE WIRE SPRING TIP AND RESULT IN DISLODGING THE GUIDE WIRE SPRING TIP. USE FLUOROSCOPY TO MONITOR MOVEMENT OF THE SHAFT TIP IN RELATION TO THE VIPERWIRE GUIDE WIRE SPRING TIP." THE MATERIAL INSPECTION RECORD FOR THIS GUIDE WIRE 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 DEVICE HISTORY RECORD FOR THE REPORTED OAD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION CONCLUSION CODE 22: THE DIAMONDBACK 360® CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES THAT VESSEL PERFORATION IS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. D10: MODEL NUMBER: GWC-12325LG-FT. CATALOG NUMBER: 7-10038-03. UDI NUMBER: (B)(4). LOT NUMBER: 453646-1. MANUFACTURING DATE: 9/21/2022. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. CSI ID: (B)(4).

    Description of Event or Problem · 0

    AFTER THREE TREATMENTS OF A HEAVILY CALCIFIED, HEAVILY TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), THE OAD CROWN JUMPED, AND THE DISTAL PART OF THE VIPERWIRE ADVANCE GUIDE WIRE FRACTURED. A PERFORATION WAS OBSERVED. THREE CORONARY COVERED STENTS WERE IMPLANTED TO TREAT THE PERFORATION AND COMPLETE THE PROCEDURE. THE DISTAL PART OF THE GUIDE WIRE WAS GREATER THAN 2.5 CENTIMETERS AND REMAINED FREE FLOATING IN THE PATIENT. IN THE PHYSICIAN'S OPINION, THERE WAS DIFFICULTY ADVANCING THE GUIDE WIRE DUE TO PATIENT ANATOMY. THE PATIENT WAS HOSPITALIZED IN STABLE CONDITION AFTER THE PROCEDURE WITH A PLAN TO BE TREATED FOR A SECOND TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363009 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. C-2DB-CL125-135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H CORONARY VIPERWIRE ADVANCE GUIDE WIRE.