BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 2253507 · Received September 19, 2011

    Report

    Report Number
    2134265-2011-03933
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    May 9, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: AN INITIAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE FOUND THAT THE DISTAL END OF THE GUIDE WIRE WAS SLIGHTLY ELONGATED AND KINKS WERE PRESENT. THE GUIDE WIRE PRESENTS SCRAPED/MISSING COATING IN FIVE LOCATIONS: 48CM FROM THE DISTAL END (APPROXIMATELY 1CM IN LENGTH), 62CM FROM THE PROXIMAL END (APPROXIMATELY 1CM IN LENGTH), 101CM FROM THE PROXIMAL END (APPROXIMATELY 3CM IN LENGTH), 40CM FROM THE DISTAL END (APPROXIMATELY 2CM IN LENGTH), 102CM FROM THE DISTAL END (APPROXIMATELY 3CM IN LENGTH). THE OVERALL LENGTH OF THE GUIDE WIRE WAS MEASURED AND FOUND TO BE 257CM. THE OUTER DIAMETER OF THE WIRE WAS MEASURED IN THREE LOCATIONS WHERE DAMAGE WAS NOT NOTED AND FOUND TO MEET SPECIFICATION. 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 UPON UNPACKING THIS .035" 260CM AMPLATZ J-TIP GUIDE WIRE FOR AN ANGIOGRAPHY PROCEDURE, THE TIP WAS "SHREDDED". THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME TYPE GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT GUIDE WIRE COATING WAS MISSING IN SEVERAL LOCATIONS.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1