BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-PER COAT DIRECT WIRE 300ST

    MDR report key: 518204 · Received February 2, 2004

    Report

    Report Number
    1220452-2004-00005
    Event Type
    Malfunction
    Date Received
    February 2, 2004
    Date of Event
    January 15, 2004
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO COMPANY THAT THE COATING ON THE WIRE WAS SCRAPED OFF DURING THE PROCEDURE. THE PHYSICIAN INSERTED THE WIRE INTO THE PT THROUGH THE GUIDE CATHETER. THE PHYSICIAN NOTICED THAT THE COATING OF THE WIRE WAS SCRAPING OFF. 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 147889

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN