BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 22209332 · Received June 16, 2025

    Report

    Report Number
    3005099803-2025-02638
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729861409
    PMA / PMN Number
    K151315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 E1: INITIAL REPORTER FACILITY NAME: (B)(6). 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 AIRWAY DURING AN ULTRASOUND BRONCHOSCOPY PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, PUNCTURE NEEDLE COULD NOT CROSS THE TRACK OF THE SHEATH AND CAME OUT FROM THE SIDE OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO PATIENT COMPLICATIONS 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
    1009272 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0035623374 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male