BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDE WIRES

    MDR report key: 483564 · Received September 16, 2003

    Report

    Report Number
    6000136-2003-00005
    Event Type
    Injury
    Date Received
    September 16, 2003
    Date of Event
    August 5, 2003
    Report Date
    August 20, 2003
    Manufacturer
    LAKE REGION MFG, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENT PROCEDURE, AFTER TREATING THE LESION WITH A CUTTING BALLOON AND STENT, THE TIP OF THE WIRE FRACTURED. THE PHYSICIAN WAS ATTEMPTING TO PLACE A SECOND STENT AND HAD TWO WIRES IN THE LESION WHEN THE TIP FRACTURE OCCURRED. THE TIP OF THE WIRE WAS REMOVED WITH A SNARE. PT STATUS IS LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRES FORTE PTCA GUIDEWIRE DQX LAKE REGION MFG, INC. FORTE-MODERATE SUPPORT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention