BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF¿

    MDR report key: 2422285 · Received January 19, 2012

    Report

    Report Number
    2134265-2012-00101
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    August 24, 2011
    Report Date
    December 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    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: THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND ANOMALIES WERE OBSERVED. IT WAS OBSERVED THAT THERE WAS A KINK AT 55 CM FROM THE PROXIMAL SECTION, ADDITIONALLY THIS SAME AREA PRESENTS THE COATING SCRAPPED. THE DEVICE APPEARS TO HAVE BEEN IN CONTACT WITH A SHARP OR METAL OBJECT. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS MFG. REPORT# 2134265-2011-05081. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. 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. RETURNED PRODUCT ANALYSIS REVEALED PEELING OF THE COATING ON THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465181

    Patients

    Seq Age Sex Outcome Treatment
    1