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

Model Number	M00558220
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).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 k151895 and k163248; reported here as premarket/510(k) exceeded the character limit for the designated field.Block h6: imdrf component code g0600601 captures the investigation analysis of punctured sheath.Block h11: an expect pulmonary needle was received for analysis.Visual examination of the returned device found the working length (near to the luer) and the needle were kinked, also, the needle punctured the sheath.The reported event was confirmed.Based on the available information, it was found that the working length was kinked near to the luer, this failure could be caused when the handle is not grabbed or secured carefully, the weight of the device itself can bent the working length, it can also happen that if excessive force is being used to grab any of the components of the device, these can fail and get affected by this manipulation.Also, the needled was kinked.Needle 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 expect pulmonary needle was used in the seven groups of lymph nodes during an endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) procedure on (b)(6) 2025.During the procedure, the needle out of the sheath had great resistance, needle appearance deformation.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.This event has been deemed a reportable event based on the investigation results; the needle punctured the sheath.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22420117
• Report Number: 3005099803-2025-03073
• Device Sequence Number: 8700085
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409(17)271008(10)35019902
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151315
• 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
• Report Date (Section B): 07/07/2025

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: 0035019902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 75 KG