BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2183496 · Received July 29, 2011

    Report

    Report Number
    2134265-2011-03122
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. ONE DEVICE WAS RECEIVED WITHOUT ITS ORIGINAL POUCH, LOADED INSIDE THE HOOP. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND COATING SCRAPED NEAR THE PROXIMAL END AND THE DISTAL TIP PRESENTS KINKS. THE WIRE PRESENTS TWO BENDS NEAR TO THE DISTAL END. THE DEVICE PRESENTS TEFLON COAT SCRAPED AT 15 CM FROM THE PROXIMAL END (LENGTH OF SECTION SCRAPED IS ABOUT OF 2 CM). 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) 2011. IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR TREATMENT PROCEDURE, A GUIDEWIRE ISSUE OCCURRED. THE PROCEDURE WAS BEING PERFORMED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE AMPLATZ S/S (B)(4) GUIDEWIRE WAS INSERTED, WHEN IT WAS NOTED THAT THE PROXIMAL END RAVELED. THE PROCEDURE WAS CONTINUED WITH ANOTHER AMPLATZ GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED MISSING COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA M001465260

    Patients

    Seq Age Sex Outcome Treatment
    1