BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2122277 · Received June 13, 2011

    Report

    Report Number
    2134265-2011-02256
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    March 5, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATED BY MANUFACTURER: VISUAL AND MICROSCOPIC ANALYSIS OF THE RETURNED DEVICE REVEALED THE DISTAL PART OF THE DEVICE WAS BENT AND LIGHTLY ELONGATED AT THE TIP. THERE WERE SEVERAL BENDS AT THE TIP OF THE WIRE. THE DEVICE PRESENTS A SECTION OF 3 CM OF LENGTH WHERE THE COATING IS DETACHED FROM COIL. THIS SECTION IS LOCATED 20 CM FROM THE DISTAL END, AND ALSO PRESENTS A SECTION OF HALF CENTIMETER OF LENGTH WHERE THE COATING IS DETACHED FROM COIL. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4)

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING PREPARATION, A GUIDE WIRE TIP KINK OCCURRED. DURING UNPACKING THE TIP OF A 035/260/3MM AMPLATZ SUPER STIFF GUIDE WIRE WAS FOUND TO BE KINKED. THE AMPLATZ GUIDE WIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. RETURNED PRODUCT ANALYSIS REVEALED COATING 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 M001465020 13871107

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR