BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1191152 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04872
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNK; THEREFORE, THE MFR AND EXPIRATION DATES CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT WHILE PASSING THE EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DOWN THE BIOPSY PORT OF THE BRONCHOSCOPE, TO PERFORM A NEEDLE ASPIRATION OF THE CARINA, IT WOULD BEND. THE NEEDLE AND CATHETER WOULD BEND AT THE DISTAL END NEAR THE SHEATHED NEEDLE AND GET HUNG UP AT THE BIOPSY PORT ENTRY AT "Y" AND ABOUT 2 INCHES DOWN. THIS MADE FOR DIFFICULTY IN UTILIZING THE NEEDLE PROPERLY, AND WITH GETTING ADEQUATE SAMPLES. EACH TIME THE NEEDLE WAS BENT BEYOND USE, ANOTHER ONE WAS OPENED AND USED; A TOTAL OF 4 WERE USED (EACH HAVING THE SAME ISSUE) TO COMPLETE THE CASE. THERE WAS NO PT INJURY. NOTE: THIS COMPLAINT IS FOR ONE OF FOUR DEVICES, PLEASE REFER TO MFR #S 3005099803-2008-04870, 3005099803-2008-04871, AND 3005099803-2008-04873 FOR THE OTHER THREE REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK