BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ

    MDR report key: 2140552 · Received June 23, 2011

    Report

    Report Number
    2140552
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE IQ GUIDE WIRE WAS ADVANCED INTO THE RAMUS INTERMEDIUS. UPON REMOVAL OF THE IQ GUIDE WIRE, IT WAS NOTED BY THE PHYSICIAN THAT THE TIP OF THE WIRE HAD BROKEN OFF DURING SOME POINT OF THE PROCEDURE. THE CATHETER TIP WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IQ GUIDEWIRE DQX BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR