BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1191092 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04904
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE BRONCHOSCOPY WHEN THEY ADVANCED THE EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE THROUGH THE BRONCHOSCOPE AND ARRIVED AT THE SITE (LEFT UPPER LOBE), THE NEEDLE WOULD NOT ASPIRATE. THE PHYSICIAN REMOVED THE DEVICE AND TRIED AGAIN; IT STILL WOULD NOT ASPIRATE. A SECOND OF THE SAME DEVICE WAS TRIED AND THE NEEDLE ON THIS DEVICE ALSO DID NOT ASPIRATE. THE PHYSICIAN REMOVED THIS DEVICE AND TRIED AGAIN UNSUCCESSFULLY. A THIRD OF THE SAME DEVICE WAS TRIED AND THE NEEDLE ON THIS DEVICE ALSO DID NOT ASPIRATE. ONCE AGAIN THE PHYSICIAN REMOVED THE DEVICE AND TRIED AGAIN UNSUCCESSFULLY. A DIFFERENT DEVICE WAS USED TO COMPLETE THE CASE. PT IS "FINE". NOTE: THIS REPORT IS FOR ONE OF THE 3 DEVICES, PLEASE REFER TO MFR #S 3005099803-2008-04903 AND 3005099803-2008-04905 FOR THE OTHER TWO REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00564121 11472715

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR