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

Model Number	M00558250
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	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary olympus was used during an ebus procedure on an unknown date.During the procedure, a small fleck of metal came out of the needle shaft.They were able to retrieve the piece.There was no patient injury due to this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: additional pro code: fcg.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.D2b: additional pro code: fcg.G4: additional premarket/510(k) #: k151895 and k163248.H11: investigation results: the returned expect pulmonary needle was received for analysis.Visual examination revealed that the device returned with the working length kinked right next to the luer.During functional inspection, the needle was extended to see if there were any detached parts and it was seen that the needle was bent.The needle was also flushed to see if there were pieces of metal inside the needle channel and there were no pieces of metal seen.The reported event was not confirmed.Based on the available information, most likely manipulation or the technique used by the physician may have been the reason the needle was kinked.When the handle is not secured carefully, the weight of the device itself can bend the device, or if excessive force is applied.Therefore, a review and analysis of all available information indicates 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 olympus was used during an ebus procedure on an unknown date.During the procedure, a small fleck of metal came out of the needle shaft.They were able to retrieve the piece.There was no patient injury due to 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21687286
• Report Number: 3005099803-2025-00892
• Device Sequence Number: 18336380
• Product Code: EOQ
• UDI-Device Identifier: 08714729861416
• UDI-Public: 08714729861416
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: M00558250
• Device Catalogue Number: M00558250
• Device Lot Number: 0034695557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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 Sex: Unknown