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	06/26/2026
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 (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.Additional clarification has been requested from the customer regarding the procedural outcome.If additional relevant information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block g4: additional premarket / 510(k) #: k163248.Block h6: device code a041001 is being used to capture the reportable event of needle punctured sheath.

• 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: 50784761
• Report Number: 3005099803-2026-03790
• Device Sequence Number: 15813317
• 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): 09/16/2026

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: 0037847806
• 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: 09/16/2026
• Date Device Manufactured: 10/31/2025
• 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: 68 YR
• Patient Sex: Male