BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 3052528 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02237
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: AFTER VISUAL INSPECTION BEFORE DECONTAMINATION PROCESS, DEVICE PRESENT THE COATING PEELED. THE VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS COATING PEELED ALONG THE BODY. ALL THE EXTERNAL OD´S MEASURES WERE TAKEN AND ALL OF THEM THE ARE ACCORDING SPECIFICATIONS. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, A GUIDE WIRE COATING ISSUE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE BLADDER, URETER, AND KIDNEY. IT WAS NOTED THAT THIS 035/145 AMPLATZ SUPER STIFF GUIDE WIRE WAS MISTAKENLY CHOSEN FOR USE DURING THE PROCEDURE. WHILE USING THIS AMPLATZ, IT WAS NOTICED THAT BLUE WIRE COATING WAS PEELING OFF THE GUIDE WIRE. THE PROCEDURE WAS CONTINUED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, A GUIDE WIRE COATING ISSUE OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE BLADDER, URETER, AND KIDNEY. IT WAS NOTED THAT THIS 035/145 AMPLATZ SUPER STIFF GUIDE WIRE WAS MISTAKENLY CHOSEN FOR USE DURING THE PROCEDURE. WHILE USING THIS AMPLATZ, IT WAS NOTICED THAT BLUE WIRE COATING WAS PEELING OFF THE GUIDE WIRE. THE PROCEDURE WAS CONTINUED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156339 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465230

    Patients

    Seq Age Sex Outcome Treatment
    1