BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2344153 · Received November 21, 2011

    Report

    Report Number
    2134265-2011-05081
    Event Type
    Malfunction
    Date Received
    November 21, 2011
    Date of Event
    August 24, 2011
    Report Date
    October 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: VISUAL AND MICROSCOPIC EXAMINATION SHOW THE DISTAL TIP OF THE DEVICE WAS TIED UP. THE DEVICE PRESENTS A KNOT NEAR TO THE DISTAL END, AND IT IS ALSO LIGHTLY ELONGATED AT THAT AREA. THE DEVICE ALSO PRESENTS A SECTION OF TEFLON COATING SCRAPED AT 54 CM FROM THE DISTAL END. THE DEVICE ALSO PRESENTS A SECTION OF TEFLON COAT SCRAPED AT 65 CM FROM THE DISTAL END AND ALSO PRESENTS A SECTION OF TEFLON COAT SCRAPED AT 110 CM FROM THE DISTAL END . 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

    IT WAS REPORTED THAT DURING A URETERAL TREATMENT PROCEDURE A KINK WAS NOTED IN THE WIRE. THE AMPLATZ S/S GW/035/145 WAS ADVANCED THROUGH THE URETER. WHILE ADVANCING THE WIRE IT KINKED AND WAS FOLDED OVER UNTO ITSELF. WENT IN WITH ANOTHER AMPLATZ S/S GW/035/145 AND THE SAME THING OCCURRED. AN UNKNOWN WIRE WAS THEN USED TO COMPLETE THE CASE SUCCESSFULLY. NO COMPLICATIONS OR INJURIES AND THE PATIENT'S STATUS IS OK. WHEN THE DEVICE WAS RETURNED TEFLON COATING WAS DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465230 14170765

    Patients

    Seq Age Sex Outcome Treatment
    1