BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ MARKER GUIDEWIRE

    MDR report key: 625202 · Received August 4, 2005

    Report

    Report Number
    6000130-2005-00399
    Event Type
    Malfunction
    Date Received
    August 4, 2005
    Date of Event
    April 2, 2005
    Report Date
    April 29, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DETERMINED REPORTABLE BASED ON ANALYSIS RECEIVED ON 07/2005. IT WAS REPORTED THAT DURING A PTCA PROCEDURE, A POLAR CATHETER LOCKED UP ON THE WIRE. THE CATHETER AND WIRE WERE REMOVED AS ONE WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ MARKER GUIDEWIRE PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC IQ MARKER WIRE 300CMM J TIP, 5 PACK 7144125

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN