BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2970277 · Received February 20, 2013

    Report

    Report Number
    2134265-2013-00832
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED THAT DURING A PERIPHERAL INTERVENTION PROCEDURE, A COATING ISSUE OCCURRED. LESION DETAILS ARE UNKNOWN. THIS XCH/035/180 HI - PREF AMPLATZ SUPER STIFF GUIDE WIRE WAS ADVANCED AND TOWARDS THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE COATING ON THE GUIDE WIRE BEGAN TO UNRAVEL. IT WAS NOTED THAT THERE WAS NO ADDITIONAL FORCE / PULLING USED DURING PROCEDURE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS CONTINUED WITH ANOTHER OF THE SAME AMPLATZ GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73995 AMPLATZ SUPER STIFF GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001465250 15763255

    Patients

    Seq Age Sex Outcome Treatment
    1