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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary was used during an endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) procedure performed on (b)(6) 2026.During the procedure, the deployment of the needle was not smooth, and the needle tip punctured out of the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary was used during an endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) procedure performed on (b)(6) 2026.During the procedure, the deployment of the needle was not smooth, and the needle tip punctured out of the sheath.The patient's condition at the conclusion of the procedure was reported to be stable.No further information has been obtained despite good faith efforts.**additional information** the procedure was completed with another of the same device.
Additional Manufacturer Narrative
Block g4: premarket / 510(k) #: k163248.Block h6: device code a041001 is being used to capture the reportable event of needle punctured sheath.
Additional Manufacturer Narrative
Additional information block b5: procedure outcome updated: the procedure was completed with another device of the same model block g4: premarket / 510(k) #: k163248 block h6: device code a041001 is being used to capture the reportable event of needle punctured sheath.Block h11: investigation results the complaint device was not returned therefore; product analysis could not be performed.For this reason and due to the lack of evidence is unable to confirm the reported event(s).It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of "needle punctured sheath" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on the information provided, the most probable cause of the reported events cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Also, for the event additional device required, it happened during the procedure, and the most probable cause of this reported issue cannot be established due to lack of evidence.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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 ; +1(914)571-6918
• MDR Report Key: 50772978
• Report Number: 3005099803-2026-03771
• Device Sequence Number: 18498048
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: M00558220
• Device Catalogue Number: M00558220
• Device Lot Number: 0038903336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 03/23/2026
• 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: 70 YR
• Patient Sex: Female