BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND¿ EX

    MDR report key: 2213260 · Received August 16, 2011

    Report

    Report Number
    2939204-2011-00419
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K931584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DEVICE ANALYSIS REVEALED A BEND AND FRACTURED AT 95.5CM FROM THE PROXIMAL END. INFORMATION AVAILABLE INDICATED THAT THE BREAK WAS OBSERVED POST UNCOILING THE GUIDEWIRE. THE DIRECTIONS FOR USE INSTRUCTS TO EXERCISE CARE IN HANDLING A GUIDEWIRE DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING OR KINKING. BASED ON DEVICE FINDINGS AND INFORMATION AVAILABLE, IT IS PROBABLE THAT THE GUIDEWIRE BREAK IS RELATED TO HANDLING OF THE DEVICE DURING THE PROCEDURE. THEREFORE, A ROOT CAUSE OF HANDLING WILL BE ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST REMOVAL FROM THE DISPENSER HOOP, THE GUIDEWIRE WAS OBSERVED TO BE BROKEN AT THE PROXIMAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST REMOVAL FROM THE DISPENSER HOOP, THE GUIDEWIRE WAS OBSERVED TO BE BROKEN AT THE PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND¿ EX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001468060 14358175

    Patients

    Seq Age Sex Outcome Treatment
    1