BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 19438347 · Received May 31, 2024

    Report

    Report Number
    3005099803-2024-02536
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    May 10, 2024
    Report Date
    May 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K163248
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: PREMARKET/ 510(K) #: K163248, K151895 . BLOCK H6: IMDRF DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DETACHED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PERFORMED ON (B)(6), 2024. DURING THE PROCEDURE, THE SCOPE WAS IN A STRAIGHT POSITION AND THE NEEDLE WOULD NOT EXTEND. AFTER MULTIPLE TRIES, THE DEVICE WAS PULLED BACK, THE NEEDLE BROKE AND DETACHED, AND A FRAGMENT WAS STUCK IN THE WALLS OF THE LUNGS. IT WAS NOTED THAT A RETRIEVAL FORCEPS WAS USED TO REMOVE THE DETACHED FRAGMENT. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299504 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552351 0032117093

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other