BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2162587 · Received July 14, 2011

    Report

    Report Number
    3005099803-2011-02378
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE (B)(6). (B)(4). 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

    A VISUAL EVALUATED WAS PERFORMED. THE REPORT OF THE NEEDLE BEING BENT WAS NOT CONFIRMED. THE NEEDLE WAS NOT BENT, HOWEVER, THE CATHETER WAS FOUND TO BE BENT/KINKED. IT IS POSSIBLE THAT THE CATHETER MAY HAVE KINKED INADVERTENTLY, DUE TO THE FORCE APPLIED TO THE DEVICE DURING ITS ADVANCEMENT INTO THE SCOPE OR TISSUE. THE STRAIN RELIEF WAS ALSO FOUND TO BE SEPARATED FROM THE HANDLE. A FUNCTIONAL EVALUATION REVEALED THAT THE NEEDLE WILL EXTEND AND RETRACT. THERE IS SLIGHT RESISTANCE WHEN EXTENDING THE NEEDLE, WHICH IS MOST LIKELY DUE TO THE KINKS FOUND IN THE DEVICE. THE SYRINGE CAN BE TIGHTENED TO THE HANDLE LUER WITHOUT ANY PROBLEM. THE ROOT CAUSE OF THE KINKING, AND DIFFICULTY ADVANCING, IS CONSIDERED AN ANTICIPATED PROCEDURAL COMPLICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    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 PERFORMED FOR A BIOPSY OF THE CARINA. ACCORDING TO THE COMPLAINANT, THE NEEDLE WAS PLACED BACK IN THE SHEATH, BUT THERE WAS A RESISTANCE WHEN PULLING IT BACK INTO THE SCOPE. AFTER SOME PULL/PUSH ATTEMPTS, THE NEEDLE CAME BACK INTO VISION; THE NEEDLE WAS FOUND TO BE BENT. WITH SOME CAUTION, THEY MANAGED TO GET THE NEEDLE OUT OF THE SCOPE. THERE WAS NO DAMAGE TO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PROCEDURE TOOK A LITTLE BIT LONGER THAN EXPECTED SO THAT THE PATIENT WAS ALREADY AWAKENING FROM SEDATION AND STARTED COUGHING. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED FOR A BIOPSY OF THE CARINA. ACCORDING TO THE COMPLAINANT, THE NEEDLE WAS PLACED BACK IN THE SHEATH, BUT THERE WAS A RESISTANCE WHEN PULLING IT BACK INTO THE SCOPE. AFTER SOME PULL/PUSH ATTEMPTS, THE NEEDLE CAME BACK INTO VISION; THE NEEDLE WAS FOUND TO BE BENT. WITH SOME CAUTION, THEY MANAGED TO GET THE NEEDLE OUT OF THE SCOPE. THERE WAS NO DAMAGE TO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PROCEDURE TOOK A LITTLE BIT LONGER THAN EXPECTED SO THAT THE PATIENT WAS ALREADY AWAKENING FROM SEDATION AND STARTED COUGHING. 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 13113259

    Patients

    Seq Age Sex Outcome Treatment
    1