BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 ATHERECTOMY SYSTEM

    MDR report key: 2181688 · Received July 22, 2011

    Report

    Report Number
    2181688
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 22, 2011
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GUIDEWIRES AND CATHETERS WERE ADVANCED TO THE POPLITEAL ARTERY, THEN TO THE PERONEAL ARTERY. A VIPER WIRE WAS PLACED AND THEN A DIAMONDBACK CATHETER WAS USED TO ATHERECTOMIZE THE TIBIA PERONEAL TRUNK ON LOW SPEED. THE SURGEON TRIED TO ADVANCE TO THE PERONEAL ARTERY WHEN THE CATHETER BECAME STUCK ON THE ACCESS WIRE, AND BOTH HAD TO BE REMOVED. THE WIRE ACCESS WAS LOST. THE SURGEON WAS ABLE TO GET CATHETERS AND WIRES BACK DOWN INTO THE PERONEAL ARTERY, AND BALLOONS WERE USED TO ANGIOPLAST. THE SURGERY WAS COMPLETED WITHOUT INJURY TO THE PATIENT.======================MANUFACTURER RESPONSE FOR DIAMONDBACK360, DIAMONDBACK 360 (PER SITE REPORTER)======================THE SURGEON TALKED TO THE REPRESENTATIVE AND WAS TOLD "YEA, I HEARD THAT SOMETIMES HAPPENS." THE SURGEON WAS GOING TO CONTACT THE COMPANY ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ATHERECTOMY SYSTEM DIAMONDBACK360 MCW CARDIOVASCULAR SYSTEMS, INC DB-SC30-150 31716

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR