BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-PER COAT DIRECT WIRE 300ST

    MDR report key: 534263 · Received March 16, 2004

    Report

    Report Number
    1220452-2004-00039
    Event Type
    Malfunction
    Date Received
    March 16, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 23, 2004
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING THE PROCEDURE THE GUIDE WIRE SEPARATED. THE PHYSICIAN USED THE GUIDE WIRE WITH A GUIDE CATHETER. THE PHYSICIAN INSERTED THE GUIDE WIRE INTO THE GUIDE CATHETER AND ADVANCED FORWARD INTO THE LESION. THE PHYSICIAN COMPLETED THE PROCEDURE AND ATTEMPTED TO RETRACT THE GUIDE WIRE AND PULLED ON THE GUIDE WIRE AND IT SEPARATED INSIDE THE GUIDE CATHETER. THE GUIDE WIRE AND THE GUIDE CATHETER WERE REMOVED TOGETHER. THE PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-PER COAT DIRECT WIRE 300ST PTCA WIRES DQT MEDTRONIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN