BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT PULMONARY

    MDR report key: 23132617 · Received September 24, 2025

    Report

    Report Number
    3005099803-2025-04806
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 20, 2025
    Report Date
    December 5, 2025
    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 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 DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DETACHED.

    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 DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF NEEDLE DETACHED. BLOCK H11: INVESTIGATION RESULTS THE EXPECT PULMONARY NEEDLE WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION REVEALED THAT THE WORKING LENGTH KINKED NEAR THE LUER AND THE NEEDLE WAS BROKEN. BASED ON THE AVAILABLE INFORMATION, THE MOST PROBABLE CAUSE OF THE OBSERVED KINKING OF THE WORKING LENGTH IS USER TECHNIQUE. IF THE HANDLE IS NOT PROPERLY SECURED DURING USE, THE WEIGHT OF THE DEVICE CAN BEND THE WORKING LENGTH. ADDITIONALLY, THE APPLICATION OF EXCESSIVE FORCE WHEN MANIPULATING DEVICE COMPONENTS CAN RESULT IN DAMAGE. IT IS ALSO LIKELY THAT THE NEEDLE BREAKAGE RESULTED FROM EXCESSIVE FORCE DURING EXTENSION OR RETRACTION. SUCH FORCE COULD LEAD TO KINKING AND SUBSEQUENT NEEDLE FRACTURE. THEREFORE, THE REVIEW AND ANALYSIS OF THE AVAILABLE INFORMATION INDICATE THAT THE MOST PROBABLE ROOT CAUSE OF THE EVENT IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE BRONCHI DURING A STENT DEPLOYMENT PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE BRONCHI DURING A STENT DEPLOYMENT PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED 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
    2431493 EXPECT PULMONARY BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00558220 0036334017 08714729861409

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male