BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2120459 · Received June 10, 2011

    Report

    Report Number
    3005099803-2011-01965
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(6) RELATES TO (B)(6) FOR THE REPORTED EVENT OF THE NEEDLE FAILING TO RETRACT. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE TO OBTAIN A BIOPSY SAMPLE IN THE TRACHEA. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WAS DRIVEN OUT OF THE SHAFT, AND THE LYMPH NODE WAS PUNCTURED. HOWEVER, THE SURGEON WAS NOT ABLE TO CREATE A VACUUM, AS THE SHAFT OF THE NEEDLE HAS BEEN LOOSENED FROM THE HANDLE. BECAUSE IT LOOSENED FROM THE HANDLE, THEY WERE UNABLE TO RETRACT THE NEEDLE. THE NEEDLE WAS ABLE TO BE REMOVED FROM THE SCOPE AND ANOTHER EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564101 0014230661

    Patients

    Seq Age Sex Outcome Treatment
    1