BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-PER COAT DIRECT WIRE 300CM

    MDR report key: 531139 · Received March 4, 2004

    Report

    Report Number
    1220452-2004-00033
    Event Type
    Malfunction
    Date Received
    March 4, 2004
    Date of Event
    February 16, 2004
    Report Date
    February 16, 2004
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE CO 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 300CM PTCA WIRES DQT MEDTRONIC, INC. NA 167131

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN