BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY

    MDR report key: 12754387 · Received November 4, 2021

    Report

    Report Number
    3005099803-2021-05775
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    October 20, 2021
    Report Date
    November 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: K163248 & K151895. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LEFT DISTAL LUNG DURING A LYMPHADENOPATHY AND PERIBRONCHIAL CUFFING PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE NEEDLE RELEASED A FILAMENT OF THE SHEATH INSIDE THE PATIENT. THE SHEATH ON THE DISTAL END DETACHED INSIDE THE PATIENT WHICH WAS REMOVED BY A TRADITIONAL ASPIRATION SYSTEM OF THE BRONCHOSCOPE. THE ORIGINAL EXPECT PULMONARY NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648837 EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0027328200 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention