BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 25218721 · Received May 19, 2026

    Report

    Report Number
    3005099803-2026-01959
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    PMA / PMN Number
    K163248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G4: ADDITIONAL PREMARKET / 510(K) #: K151315. BLOCK H6: IMDRF DEVICE CODE A041001 CAPTURES THE REPORTABLE EVENT OF "NEEDLE PUNCTURED SHEATH". BLOCK E1: INITIAL REPORTER PHONE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA WAS USED FOR AN ULTRASOUND BRONCHOSCOPIC BIOPSY PROCEDURE PERFORMED ON (B)(6) 2026. IN PREPARATION TO THE PROCEDURE, THE ULTRASOUND NEEDLE EMERGED FROM THE SIDE OF THE SHEATH. ANOTHER EXPECT PULMONARY OLYMPUS 22GA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174247 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0037547815 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1