BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUICK-CROSS SELECT

    MDR report key: 1870694 · Received October 7, 2010

    Report

    Report Number
    MW5017723
    Event Type
    Death
    Date Received
    October 7, 2010
    Date of Event
    September 26, 2010
    Report Date
    October 5, 2010
    Manufacturer
    SPECTRANETICS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DISTAL PART OF CATHETER BROKE OFF IN PT "STEM" WHILE CARDIOLOGIST WAS PULLING BACK. DATE OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: HELPS CROSS BLOCKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK-CROSS SELECT CATHETER, SUPPORT DQO SPECTRANETICS 518-081 BELIEVED TO BE CQX08L20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death