BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3030081 · Received April 2, 2013

    Report

    Report Number
    2134265-2013-01879
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND VISUAL INSPECTION DETERMINED THAT THE COIL WAS UNRAVELED AND THE WIRE FRACTURED IN TWO PIECES. THE PROXIMAL SECTION (#1) WAS FRACTURED AT 142.4CM AND THE DISTAL SECTION (#2) WAS FRACTURED AT 1.1CM FROM THE DISTAL END. DIMENSIONAL INSPECTION WAS PERFORMED AND ALL MEASUREMENTS WERE WITHIN SPECIFICATION. THE GUIDEWIRE OVERALL LENGTH COULD NOT BE MEASURE DUE TO THE DEVICE FRACTURED IN TWO SECTIONS. THE COMPLAINT DEVICE WAS SENT FOR EXTERNAL ANALYSIS (MTAC LAB) TO DETERMINE THE FRACTURE FAILURE MODE AND MTAC ANALYSIS DETERMINED: ONE FAILURE ON EACH SAMPLE WAS FOUND AND CHARACTERIZED. FAILURE ON SECTION #1 WAS DEFINED AS A FATIGUE EVENT IN A CYCLIC BENDING MOMENT; AND FAILURE ON SECTION #2 WAS DETERMINED AS A TORSION OVERLOAD WITH A BENDING MOMENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2013. IT WAS REPORTED THAT DURING TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, A GUIDEWIRE TIP BECAME STRETCHED. LESION DETAILS ARE UNKNOWN. UPON COMPLETION OF THE PROCEDURE, THIS ST/035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS BEING WITHDRAWN OUT OF AN UNKNOWN GUIDE CATHETER WHEN IT WAS NOTICED THAT THE GUIDEWIRE TIP STARTED TO "FRAY" (STRETCH). THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH THIS AMPLATZ GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A FRACTURED GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134073 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465240 15255139

    Patients

    Seq Age Sex Outcome Treatment
    1