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); Use of Device Problem (1670); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable investigation result of sheath puncture.Block h11: investigation results an acquire pulmonary needle was received for analysis.Visual examination of the returned device revealed that the sheath was punctured, and the handle knobs were able to adjust without problems.The needle was observed kinked inside the handle and the needle tip was observed kinked.Based on the available information, the investigation findings were most likely that the physician technique was the reason why the needle was found kinked inside of the handle, if excessive force is used in order to complete the punctures needle in the procedure, it's possible that the needle is going to be affected by this manipulation.It's possible that during the procedure, due to the tortuosity of the procedure, the needle wasn't advancing as smooth as it should be and due to this pressure, more force than adequate was used leading to the needle being kinked.Also, the needle tip kinked could be caused if excessive force is used in order to complete the punctures needle in the procedure, and if it was tried to extend the needle while it is bent it can cause the sheath to be punctured.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an acquire pulmonary needle was used in rectum during an endobronchial ultrasound-guided transbronchial needle aspiration (ebus tbna) procedure on (b)(6)2025.During the procedure, the sheath from the needle pushes back into the working channel although the sheath was locked with the knob and puncture was not possible.The sheath advancement changes significantly even with proper fixation when angulating the ebus device and must be readjusted after each removal and reinsertion of the needle, which is very time-consuming.A non bsc device was used to complete the procedure there were no reported patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results; the sheath was punctured.Please see block h11 for full investigation details.

• 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: 23442243
• Report Number: 3005099803-2025-05386
• Device Sequence Number: 8672334
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409(17)280115(10)35633453
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163248
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: 0035633453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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