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

Model Number	M00558250
Medical Device Problem Codes	Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary olympus 22ga was used for mediastinal lymph node in the lungs during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2026.During the procedure, it was reported that the luer lock was cracked, after about 7 passes of the needle, making it impossible to flush the needle with water or air to expel the specimen.Additionally, little black pieces of foreign material were found in the specimen jar.The procedure was completed with another needle.There were no patient complications reported as a result of this event.

• 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: 24852033
• Report Number: 3005099803-2026-01317
• Device Sequence Number: 18403915
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: (01)08714729861416(17)280602(10)36665634
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: M00558250
• Device Catalogue Number: M00558250
• Device Lot Number: 0036665634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 06/03/2025
• 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