BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT DIAMOND BACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 18130539 · Received November 13, 2023

    Report

    Report Number
    MW5148076
    Event Type
    Death
    Date Received
    November 13, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 9, 2023
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERFORMING A PERCUTANEOUS CORONARY INTERVENTION USING A CSI(CARDIOVASCULAR SYSTEMS, INC.) ATHERECTOMY DEVICE. DEVICE SHEERED THE MID-PORTION OF THE WIRE LEAVING THE RADIOLUCENT DISTAL PORTION GIVING THE APPEARANCE THAT THE WIRE WAS STILL INTACT ALTHOUGH IT WAS SHEERED OFF. SUBSEQUENTLY CAUSING THE DEVICE TO NOT HAVE A RAIL LEADING TO A PERFORATION OF THE LEFT MAIN ARTERY. CONCERNS REGARDING THIS DEVICE IS THAT THE 2 DIFFERENT WIRES WITH 2 DIFFERENT DIAMOND BACK DEVICES LED TO THE WIRE SHEARING/BREAKING OFF. THERE SHOULD BE SOME INVESTIGATION INTO SOME MALFUNCTION INTO THE WIRE SINCE WE HAVE NEVER ENCOUNTERED THIS ISSUE BEFORE. THERE WAS DIFFICULTY ADVANCING DEVICE WHICH WE ASSUME TO BE DUE TO THE DEFECT. RECOMMEND SOME KIND OF SAFETY MECHANISM INCORPORATED INTO THE DEVICE WHERE IF NO DISTAL WIRE IS SENSED PAST THE ORBITAL ATHERECTOMY DEVICE THAT IT WILL AUTOMATICALLY SHUT OFF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153193 ABBOTT DIAMOND BACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED 485414

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death VIPER WIRE FOR DIAMONDBACK