BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2920046 · Received January 17, 2013

    Report

    Report Number
    2134265-2013-00393
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    October 30, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: A VISUAL INSPECTION WAS PERFORMED AND THE COMPLETE WIRE LENGTH WAS RETURNED. THE FOLLOWING DAMAGE WAS NOTED TO THE DEVICE; THE DISTAL TIP WAS FRACTURED ON THE BALLWELD AND UNRAVELED AND THE DEVICE HAS A KINK AT 68.6CM FROM THE PROXIMAL END. THE OUTER DIAMETER OF THE WIRE WAS MEASURED AT THE PROXIMAL, MID AND DISTAL SECTIONS AND FOUND TO BE WITHIN SPECIFICATION. THE RETURNED DEVICE WAS SENT FOR EXTERNAL LAB ANALYSIS TO DETERMINE THE FRACTURE FAILURE MODE. THE EXTERNAL LAB RETURNED THE FOLLOWING RESULTS: THE FAILURE OCCURRED DUE TO A TENSION OVERLOAD EVENT. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2012. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE GUIDE WIRE UNRAVELED. THE TARGET VESSEL BEING TREATED WAS LOCATED IN THE COLON. AN 0.035" AMPLATZ SUPER STIFF GUIDE WIRE WAS ADVANCED TO THE VESSEL. THE AMPLATZ SUPER STIFF GUIDE WIRE WAS SUCCESSFULLY USED FOR TREATMENT. THE AMPLATZ GUIDE WIRE WAS REMOVED IN THE NORMAL WAY FROM AN UNSPECIFIED NON-BSC COLONIC STENT CATHETER. RESISTANCE WAS EXPERIENCED. THE GUIDE WIRE WAS FULLY CONTAINED WITHIN THE CATHETER LUMEN WHEN THE RESISTANCE OCCURRED. ONCE OUTSIDE THE BODY IT WAS NOTED THAT THE COIL WIRE HAD UNRAVELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THE GUIDE WIRE HAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26419 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465250 15241110

    Patients

    Seq Age Sex Outcome Treatment
    1