BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 16368457 · Received February 13, 2023

    Report

    Report Number
    3005099803-2023-00334
    Event Type
    Injury
    Date Received
    February 13, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 DETACHMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE LUNG DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE ACQUIRE NEEDLE FRACTURED AND LODGED ITSELF IN THE MUCOSA OF THE TRACHEA. IT WAS REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ACQUIRE PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654938 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 0030049188 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention