BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 22202918 · Received June 13, 2025

    Report

    Report Number
    3005099803-2025-02636
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861416
    PMA / PMN Number
    K151315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: THE REMAINING PRO CODE (PRODUCT CODE) IS FCG; REPORTED HERE AS PRO CODES (PRODUCT CODES) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G4: THE REMAINING PREMARKET/510(K) ARE K151895 AND K163248; REPORTED HERE AS PREMARKET/510(K) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF PUNCTURED SHEATH.

    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 EBUS (ENDOBRONCHIAL ULTRASOUND) BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE NEEDLE CAME OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636630 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558250 08714729861416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown