BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACQUIRE PULMONARY

    MDR report key: 16795821 · Received April 24, 2023

    Report

    Report Number
    3005099803-2023-02056
    Event Type
    Injury
    Date Received
    April 24, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729986225
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED IN THE MEDIASTINAL LYMPH NODES DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, ABOUT 1 CM OF THE NEEDLE DISTAL TIP DETACHED. THE PROCEDURE WAS IMMEDIATELY STOPPED AND A SEARCH FOR THE TIP OF THE NEEDLE IN THE PATIENT AIRWAY, ENDOTRACHEAL TUBE, AND THE EXTERNAL AREA AROUND THE PATIENT WAS UNSUCCESSFUL. THE PATIENT WAS MOVED TO A FLUOROSCOPY BED, AND THEY SEARCHED THE PATIENT'S LUNGS RADIOLOGICALLY USING FLUOROSCOPY AND 3D FLUOROSCOPY BUT COULD NOT LOCATE THE MISSING NEEDLE TIP. DURING CLEANING, THE TECH BRUSHED THE MISSING NEEDLE TIP OUT OF THE PROXIMAL END OF THE SCOPE. THE PROCEDURE WAS COMPLETED USING A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442306 ACQUIRE PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 0030922028 08714729986225

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention