BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUIRE? PULMONARY

    MDR report key: 23268402 · Received October 10, 2025

    Report

    Report Number
    3005099803-2025-04925
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K163248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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 G4: THE REMAINING PREMARKET/510(K) ARE K151315 AND K151895; REPORTED HERE AS PREMARKET/510(K) EXCEEDED THE CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF ABSENCE OF TREATMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ACQUIRE PULMONARY NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE ON (B)(6) 2025. UPON UNPACKING, THE VALVE WAS BROKEN. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, HOWEVER IT WAS NOTED THAT THE PATIENT WAS HOSPITALIZED OR THEIR HOSPITALIZATION WAS PROLONGED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE HOSPITALIZATION, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303936 ACQUIRE? PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00552350 0034218335

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown