MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPECT PULMONARY; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	M00558220
Medical Device Problem Codes	Mechanical Problem (1384); Material Puncture/Hole (1504); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of punctured sheath.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the bronchus during an endobronchial ultrasound (ebus) procedure on (b)(6) 2025.During the procedure, it was very difficult and required considerable force to advance the needle.The expect was removed from the endoscope.It was tested again outside of the patient, and the needle pierced the sheath.The procedure was completed using another expect pulmonary needle.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary needle was used in the bronchus during an endobronchial ultrasound (ebus) procedure on (b)(6) 2025.During the procedure, it was very difficult and required considerable force to advance the needle.The expect was removed from the endoscope.It was tested again outside of the patient, and the needle pierced the sheath.The procedure was completed using another expect pulmonary needle.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of punctured sheath.Block h11: investigation results: the returned expect pulmonary needle was received for analysis.During the media inspection, it was seen that the sheath is torn at the tip, visual and microscope inspection, revealed that the sheath tip was punctured by the needle and the sheath was also found kinked right next to the luer.During the functional inspection, it was seen that the needle was able to extend; however, pressure was felt from the handle when extending the needle.The reported event was confirmed.Based on the available information, it is most likely procedural factors as handling of the device and the technique (force applied), could have resulted in the damages (working length kinked right next to the luer and at the tip) encountered in the device.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• Brand Name: EXPECT PULMONARY
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23849730
• Report Number: 3005099803-2025-06801
• Device Sequence Number: 9958246
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409(17)280515(10)36536167
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558220
• Device Catalogue Number: M00558220
• Device Lot Number: 0036536167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown