BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY OLYMPUS 22GA - BOX 5

    MDR report key: 16356518 · Received February 10, 2023

    Report

    Report Number
    3005099803-2023-00150
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K)#: K163248 & K151895. . DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DISTAL TIP DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE TRACHEOBRONCHIAL TREE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, APPROXIMATELY 3MM AND 4MM NEEDLE FILAMENTS CAME OUT AFTER THE 5TH PUNCTURE. BOTH WERE REMOVED FROM THE PATIENTS' TRACHEOBRONCHIAL TREE WITH FORCEPS. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48411 EXPECT PULMONARY OLYMPUS 22GA - BOX 5 BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558221 0030421184 08714729861430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention