BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 498912 · Received November 26, 2003

    Report

    Report Number
    6000136-2003-00007
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Date of Event
    August 26, 2003
    Report Date
    September 11, 2003
    Manufacturer
    LAKE REGION MFG, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PRIOR TO A PTA PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WAS BENT. THE GUIDEWIRE WAS NOT USED FOR THE PROCEDURE. ANOTHER WIRE WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PT IS REPORTED AS 'FINE'; NO INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER GUIDEWIRE PTA GUIDE WIRE DQX LAKE REGION MFG, INC. NA 01947784

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN