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

Model Number	M00558220
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• 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: 23132617
• Report Number: 3005099803-2025-04806
• Device Sequence Number: 18621118
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409(17)280420(10)36334017
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 0036334017
• 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: 09/01/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 68 KG