MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Expect Pulmonary; bronchoscope (flexible or rigid)

Model Number	M00558220
Medical Device Problem Codes	Break (1069); Difficult to Flush (1251); Mechanical Problem (1384); Material Puncture/Hole (1504); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an expect pulmonary olympus 22ga was used during an endobronchial ultrasound (ebus) procedure performed on (b)(6) 2026.During the procedure, the needle cracked at the top causing it not to hold suction or flush out material.The needle was not able to advance since it got caught in the tip of the sheath causing the sheath to be punctured.The procedure was completed with another expect pulmonary olympus 22ga.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4,h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.Block h2 correction h6 device codes and b5 block h6 imdrf device code a041001 captures the reportable event of "needle punctured sheath".Block h11 device evaluation the device was not returned for analysis; therefore, a technical analysis could not be performed.The customer provided a picture where it can be observed the sheath punctured.For this reason, the reported code of "needle punctured sheath" could be confirmed.However, it was unable to confirm the reported codes of "handle break", "needle failure to extend", "device suction issue" and "device difficult to flush" with the evidence provided.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 all the gathered information, 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: 25864043
• Report Number: 3005099803-2026-02924
• Device Sequence Number: 5532565
• Product Code: EOQ
• UDI-Device Identifier: 08714729861409
• UDI-Public: (01)08714729861409
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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 Expiration Date: 06/28/2026
• Device Model Number: M00558220
• Device Catalogue Number: M00558220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 06/29/2026
• 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 Sex: Unknown