BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPECT PULMONARY

    MDR report key: 15666094 · Received October 25, 2022

    Report

    Report Number
    3005099803-2022-05816
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    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. BLOCK H6: DEVICE CODE A180104 CAPTURES THE REPORTABLE EVENT OF FOREIGN MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN NEEDLE WAS EXTERIORIZED INSIDE THE PATIENT IT WAS NOTICED THE EXIT OF A METALLIC FILAMENT SIMILAR TO THE STYLET; HOWEVER, THE STYLET WAS FINE WHEN OBSERVED. A PHOTO OF THE FILAMENT WAS PROVIDED BY THE CUSTOMER, BUT IT IS UNKNOWN WHERE THE FILAMENT CAME FROM. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT 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
    2744330 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0029785913 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown