BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2223574 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02754
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    May 16, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. (B)(4). THE RETURNED EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS EVALUATED. A VISUAL EVALUATION WAS PERFORMED. THE REPORT OF THE NEEDLE NOT BEING ABLE TO EXIT THE SHEATH WAS CONFIRMED. THE SHEATH IS SLIGHTLY BUCKLED APPROXIMATELY 3CM FROM THE DISTAL TIP. THE NEEDLE WAS ALSO FOUND TO BE PROTRUDING FROM THE SIDE OF THE SHEATH. IT IS POSSIBLE THAT THE DEVICE MAY HAVE BEEN BENT DURING PREPARATION AND WHEN AN ATTEMPT WAS MADE TO EXTEND THE NEEDLE, IT PUNCTURED THE SHEATH. HOWEVER, THE EXACT ROOT CAUSE IS UNDETERMINABLE. THE SYRINGE IS ATTACHED TO THE HANDLE. THE SYRINGE WAS REMOVED FROM THE DEVICE AND FOUND THAT THE HANDLE LUER HAD BEEN STRIPPED. A FUNCTIONAL EVALUATION WAS PERFORMED. THE SYRINGE WAS ABLE TO BE TIGHTENED ONTO THE LUER, EVEN THOUGH THE LUER WAS STRIPPED. THE SHEATH WAS ABLE TO BE SLIGHTLY STRETCHED AND THE NEEDLE WAS ABLE TO BE REALIGNED WITH THE HUB. ONCE THE NEEDLE WAS REALIGNED WITH THE HUB, THE NEEDLE COULD BE EXTENDED AND RETRACTED. INITIALLY, THE NEEDLE MAY HAVE BEEN STUCK BETWEEN THE SHEATH AND THE HUB. 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 (TBAN) DEVICE WAS USED DURING A BRONCHOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING TESTING, THE NEEDLE WOULD NOT EXIT THE SHEATH; IT APPEARED TO GET STUCK BEHIND THE NEEDLE HUB. THE NEEDLE NEVER EXITED THE SHEATH, AND DID NOT PUNCTURE THE SIDE OF THE SHEATH. ANOTHER 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. THIS REPORT IS CONSIDERED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS OF THE NEEDLE BEING FOUND PROTRUDING THE SHEATH.

    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 M00564121 14222375

    Patients

    Seq Age Sex Outcome Treatment
    1