BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1102028 · Received August 7, 2008

    Report

    Report Number
    3005099803-2008-01578
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. THE 2008 15-MONTH PULMONARY BIOPSY NEEDLE PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF THREE EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MANUFACTURER REPORTS 3005099803-2008-01583 AND 3005099803-2008-01581 FOR A DESCRIPTION OF THE THIRD EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE (TBAN) WAS USED DURING A BRONCHIAL PROCEDURE IN THE SAME MONTH. ACCORDING TO THE COMPLAINANT, THE NEEDLE WOULD NOT ASPIRATE AND THE SYRINGE CONNECTION WAS LOOSE. THE PHYSICIAN ATTEMPTED TO COMPLETE THE PROCEDURE WITH A THIRD EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00564121 9240559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK