BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 4170641 · Received October 14, 2014

    Report

    Report Number
    3004742232-2014-00051
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 8, 2014
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE MATERIAL INSPECTION REPORT FOR THIS VIPERWIRE LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE WIRE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI CORONARY VIPERWIRE GUIDEWIRE FRACTURED OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESION WAS 90% OCCLUDED AND WAS LOCATED IN THE MID-RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ADVANCED THE CSI GUIDEWIRE INTO THE PATIENT AND ACROSS THE LESION. THE PHYSICIAN THEN LOADED A CSI ORBITAL ATHERECTOMY DEVICE (OAD) ONTO THE GUIDEWIRE. THE PHYSICIAN COMPLETED THREE RUNS AT LOW SPEED AND THREE RUNS AT HIGH SPEED. IT WAS OBSERVED THAT DURING THE FINAL RUN, THE PHYSICIAN CAME TOO CLOSE TO THE GUIDEWIRE TIP AND A GUIDEWIRE FRACTURE OCCURRED. THE CSI INSTRUCTIONS FOR USE (IFU) STATES, "DO NOT COME WITHIN 5MM OF THE PROXIMAL END OF THE VIPERWIRE GUIDEWIRE SPRING TIP WITH THE DISTAL END OF THE OAD DRIVESHAFT. IF THE DISTANCE BETWEEN THE SHAFT TIP AND THE VIPERWIRE GUIDEWIRE IS INSUFFICIENT, THE SHAFT TIP MAY CONTACT THE GUIDEWIRE SPRING TIP AND RESULT IN DISLODGING THE GUIDEWIRE SPRING TIP." A SMALL PORTION (ABOUT 5MM) OF THE GUIDEWIRE WAS LEFT IN A NON-OBSTRUCTING CORONARY ARTERY BRANCH. THE PHYSICIAN COMPLETED THE INTERVENTION VIA BALLOON ANGIOPLASTY FOLLOWED BY STENT PLACEMENT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650907 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS INCORPORATED GWC-12325LG-FLP 10395125

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention