BEUDAMED
    FDA Adverse Event Death Summary report: N

    CSI DIAMONDBACK 360 CORONARY CLASSIC ATHERECTOMY SYSTEM

    MDR report key: 7365064 · Received March 22, 2018

    Report

    Report Number
    MW5075979
    Event Type
    Death
    Date Received
    March 22, 2018
    Date of Event
    March 9, 2018
    Report Date
    March 21, 2018
    Manufacturer
    CARDIOVASCULAR SYSTEM INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CSI - OAS DIAMONDBACK 360 CORONARY CLASSIC GUIDEWIRE LOT # 191513 BROKE DURING PROCEDURE AND WAS UNABLE TO BE RETRIEVED RESULTING IN PATIENT REQUIRING OPEN HEART SURGERY. CATHETER INSERTED BY GUIDEWIRE, LEFT CORONARY SYSTEM INJECTED AND MULTIPLE VIEWS TAKEN. WIRE EXCHANGED FOR A PT2X300 OVER A 1.5X20 BALLOON, RT2 INSERTED INTO THE CIRCUMFLEX, CORONARY ARTERY VISUALIZED, INTERVENTIONAL WIRE REMOVED, INTERVENTIONAL GUIDEWIRE INSERTED. PT2X300 REINSERTED, INTERVENTIONAL WIRE REMOVED, INTERVENTIONAL GUIDEWIRE REINSERTED, VIPERWIRE REINSERTED, CORONARY ARTERY VISUALIZED, PTCA BALLOON REMOVED, CORONARY ARTERY VISUALIZED, VIPERWIRE SHEARED AND DISTAL PIECE OF WIRE REMAINS IN CIRCUMFLEX ARTERY. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: CARDIAC ARTERY DISEASE (70 PERCENT DISTAL LEFT MAIN, 80 PERCENT CIRC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207643 CSI DIAMONDBACK 360 CORONARY CLASSIC ATHERECTOMY SYSTEM OAS DIAMONDBACK 360 CORONARY CLASSIC GUIDEWIRE MCW CARDIOVASCULAR SYSTEM INC. 1.25 CLASSIC 191513

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death