BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-PER COAT DIRECT WIRE 300CM STRAIGHT

    MDR report key: 495361 · Received November 10, 2003

    Report

    Report Number
    1220452-2003-00143
    Event Type
    Malfunction
    Date Received
    November 10, 2003
    Date of Event
    October 25, 2003
    Report Date
    October 27, 2003
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COATING ON THE WIRE WAS SCRAPED OFF DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE WIRE INTO THE PATIENT AND THEN INSERTED THE GUIDE INTO PATIENT. THE PHYSICIAN REMOVED THE GUIDE AND NOTICED THAT THE COATING OF THE WIRE WAS SCRAPING OFF. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-PER COAT DIRECT WIRE 300CM STRAIGHT PTCA WIRES DQT MEDTRONIC, INC. NA 147889

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN