BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON¿

    MDR report key: 2991616 · Received March 6, 2013

    Report

    Report Number
    3005099803-2013-01210
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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) FOR THE REPORTED EVENT OF NEEDLE FAILING TO RETRACT. (B)(4) FOR THE REPORTED EVENT OF NEEDLE BEING BENT. 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.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT #3005099803-2013-01211 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DEVICES WAS USED DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE IN THE RIGHT LUNG BETWEEN THE UPPER AND LOWER LOBE TRYING TO PUSH THE NEEDLE OUT, THE NEEDLE BECAME KINKED AND WOULD NOT RETRACT EASILY. THE SAME INCIDENT OCCURRED WITH A SECOND NEEDLE. A THIRD EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS ABLE TO BE 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
    94836 EXCELON¿ BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC - SPENCER M00564121 0014849076

    Patients

    Seq Age Sex Outcome Treatment
    1