BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2111931 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-01943
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    February 28, 2011
    Report Date
    May 6, 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: UNDER 18 YEARS. DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. AN EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL PART OF THE WIRE WAS SLIGHTLY ELONGATED AND THE DISTAL TIP BENT. THE DEVICE PRESENTS A 3CM LONG SECTION WHERE THE COATING IS MISSING LOCATED 37CM FROM THE PROXIMAL END. THE OUTER DIAMETER OF THE WIRE WAS FOUND TO MEET SPECIFICATION. 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 ATRIAL SEPTAL DEFECT TREATMENT PROCEDURE, GUIDE WIRE TRACKING DIFFICULTIES OCCURRED. THE PHYSICIAN WAS USING TWO GUIDE WIRES, ONE OF WHICH WAS THIS .035" AMPLATZ SUPER STIFF GUIDE WIRE IN MODERATELY TORTUOUS ANATOMY. THE PHYSICIAN NOTED THAT THERE WAS MORE DIFFICULTY TRACKING OVER THE AMPLATZ WIRE IN COMPARISON TO THE OTHER WIRE. THE DEVICE DID NOT BECOME STUCK TO THE AMPLATZ. THERE WAS NO MISSING COATING NOTED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, RETURNED DEVICE 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 M001465091 13810377

    Patients

    Seq Age Sex Outcome Treatment
    1