BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 24878726 · Received April 14, 2026

    Report

    Report Number
    3005099803-2026-01361
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    UDI-DI
    08714729861409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): ADDITIONAL PRO CODE: EOQ. BLOCK G4: PREMARKET / 510(K) #: K151315, K151895, K163248. BLOCK H3: THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE OR IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. BLOCK H6: DEVICE CODE A041001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF NEEDLE PUNCTURED SHEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA NEEDLE WAS USED FOR AN ENDOBRONCHIAL ULTRASOUND NEEDLE BIOPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE NEEDLE. IT WAS THEN OBSERVED THAT THE NEEDLE HAD ADVANCED THROUGH THE SIDE OF THE SHEATH INSTEAD OF THROUGH THE DISTAL TIP, RESULTING IN A PUNCTURE TO THE SHEATH. THE USER STOPPED THE PROCEDURE AND WITHDREW THE SCOPE AND NEEDLE. ANOTHER EXPECT PULMONARY OLYMPUS 22GA NEEDLE WAS OPENED AND USED TO SUCCESSFULLY CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78428 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) FCG BOSTON SCIENTIFIC CORPORATION M00558220 0038174519 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1