BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1133475 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03837
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED. THE 2008, 15-MONTH PULMONARY BIOPSY NEEDLE PRODUCT FAMILY COMPLAINT 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 FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2008-01XXX, FOR A DESCRIPTION OF THE OTHER EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN A LUNG BIOPSY PROCEDURE THREE DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE NEEDLE GOT STUCK INSIDE THE SHEATH AND POPPED THROUGH THE OUTSIDE OF THE SHEATH. THE PHYSICIAN USED HIS HAND TO STRAIGHTEN IT OUT, POPPED IT BACK IN, AND DREW IT OUT. HE WAS ABLE TO GET THE SPECIMEN OUT OF THE NEEDLE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00564121 0011570083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK