BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    MDR report key: 2111956 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01923
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF NEEDLE FAILING TO RETRACT. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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

    EVENT DATE IS (B)(6) 2011. BASED ON THE ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO RETRACTION ISSUES WITH THE NEEDLE, THIS EVENT IS NO LONGER A MDR REPORTABLE EVENT.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED IN THE BRONCHIAL TREE. ACCORDING TO THE COMPLAINANT, IT WAS VERY DIFFICULT TO INSERT THE CATHETER INTO THE WORKING CHANNEL OF THE ENDOSCOPE. IT WAS ALSO DIFFICULT TO "EXTRACT" THE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRANSBRONCHIAL ASPIRATION NEEDLE DEVICE WAS USED DURING A BIOPSY PROCEDURE PERFORMED IN THE (B)(6). ACCORDING TO THE COMPLAINANT, IT WAS VERY DIFFICULT TO INSERT THE CATHETER INTO THE WORKING CHANNEL OF THE ENDOSCOPE. IT WAS ALSO DIFFICULT TO "EXTRACT" THE NEEDLE. THERE WERE NO PATIENT COMPLICATIONS DURING THE PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON (B)(6) 2011 ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT CONFIRMING THE DEFECT WAS THAT IT WAS DIFFICULT TO ADVANCE THE BLUE BUTTON ON THE HANDLE AND THE NEEDLE COULD NOT BE EXTENDED. THE COMPLAINANT ALSO CONFIRMED THERE WAS NO DIFFICULTY RETRACTING THE NEEDLE.

    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 13975077

    Patients

    Seq Age Sex Outcome Treatment
    1