BEUDAMED
    FDA Adverse Event Injury Summary report: N

    .035" BACK-UP MEIER STEERABLE GUIDE WIRE

    MDR report key: 610610 · Received June 2, 2005

    Report

    Report Number
    6000130-2005-00347
    Event Type
    Injury
    Date Received
    June 2, 2005
    Date of Event
    April 19, 2005
    Report Date
    May 3, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DIAGNOSTIC PROCEDURE, THE TIP OF THE MEIER GUIDE WIRE FRACTURED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE FRACTURED PORTION WITH A BIOPSY FORCEPS. ADDITIONAL INFORMATION REGARDING THIS COMPLAINT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .035" BACK-UP MEIER STEERABLE GUIDE WIRE PTA GUIDE WIRE DQH BOSTON SCIENTIFIC NA 6723269

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention