BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2123083 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-02020
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. A VISUAL INSPECTION FOUND THE NEEDLE TO BE RETRACTED, AND THE HANDLE LUER TO BE STRIPPED. THE REPORT OF THE NEEDLE BEING UNABLE TO RETRACT WAS NOT ABLE TO BE CONFIRMED. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE NEEDLE WAS ABLE TO BE EXTENDED AND RETRACTED WITHOUT DIFFICULTY. HOWEVER, THE REPORT OF LUER DAMAGE WAS CONFIRMED. THE SYRINGE WAS UNABLE TO BE TIGHTENED ONTO THE HANDLE LUER, DUE TO THE THREADS OF THE HANDLE LUER BEING STRIPPED. BASED ON THE ANALYSIS OF THIS COMPLAINT AND THE INFORMATION PROVIDE THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE (TBAN) DEVICE WAS USED DURING A BIOPSY PROCEDURE AT THE CARINA. ACCORDING TO THE COMPLAINANT, THE NEEDLE COULD BE EXTENDED BUT NOT RETRACTED. THE COMPLAINANT ALSO NOTED THAT THERE APPEARED TO BE DAMAGE TO THE THREADS OF THE SYRINGE. A SECOND TBAN 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 FINE.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE (TBAN) DEVICE WAS USED DURING A BIOPSY PROCEDURE AT THE CARINA. ACCORDING TO THE COMPLAINANT, THE NEEDLE COULD BE EXTENDED BUT NOT RETRACTED. THE COMPLAINANT ALSO NOTED THAT THERE APPEARED TO BE DAMAGE TO THE THREADS OF THE SYRINGE. A SECOND TBAN 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 FINE.

    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 14192164

    Patients

    Seq Age Sex Outcome Treatment
    1