BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON¿

    MDR report key: 2945660 · Received February 6, 2013

    Report

    Report Number
    3005099803-2013-00503
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    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

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. (B)(4) THE TIP DETACHING. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 ASSESSMENT OF THE RETURNED DEVICE WAS PERFORMED AND REVEALED THAT THE TIP OF THE NEEDLE WAS EXTENDED WHEN RECEIVED. THE DRIVE WIRE WAS DETACHED FROM THE PROXIMAL END OF THE NEEDLE; HOWEVER, THE NEEDLE WAS CONTAINED IN THE SHEATH AS DESIGNED. THE DISTAL END OF THE WIRE WHERE IT IS WELDED TO THE NEEDLE WAS DISCOLORED AND DEFORMED. THERE WAS EVIDENCE ON THE NEEDLE AND DRIVE WIRE TO INDICATE WELDING DURING MANUFACTURING. THE WORKING LENGTH WAS BENT APPROXIMATELY 12CM FROM THE DISTAL END OF THE STRAIN RELIEF, IT WAS ALSO MEASURED AND FOUND TO BE WITH SPECIFICATION. A FUNCTIONAL EVALUATION WAS PERFORMED AND FOUND THAT THE DRIVE WIRE COULD BE ACTUATED. THE DEVICE EVALUATION FOUND THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. REPORTEDLY, THE DEFECT WAS IDENTIFIED OUTSIDE THE PATIENT DURING PREPARATION FOR THE PROCEDURE; MOST LIKELY, THE DEFECTS NOTED ARE DUE TO SOME ASPECT OF HANDLING THE DEVICE PRIOR TO USE IN THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE REPORTED EVENT IS HANDLING DAMAGE. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, THE NEEDLE WAS FOUND TO BE DETACHED AT THE DISTAL END. THIS WAS NOTICED PRIOR TO USE. NO DAMAGE WAS NOTED TO THE DEVICE OR THE DEVICE PACKAGING. ANOTHER EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING, THE NEEDLE WAS FOUND TO BE DETACHED AT THE DISTAL END. THIS WAS NOTICED PRIOR TO USE. NO DAMAGE WAS NOTED TO THE DEVICE OR THE DEVICE PACKAGING. ANOTHER EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50354 EXCELON¿ BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564121 0015312330

    Patients

    Seq Age Sex Outcome Treatment
    1