MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE Pulmonary; bronchoscope accessory

Model Number	M00550350
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the lung during a bronchoscopic dilation procedure for tracheal stenosis performed on (b)(6) 2026.During the procedure, the pressure of the pump connected to the balloon remained unchanged.Upon removal and testing of the balloon, leakage was identified.A video clip of the complaint device was provided and showed that the balloon was leaking.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital; reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a0504 captures the reportable event of balloon leak in a pulmonary anatomy location.

• Brand Name: CRE Pulmonary
• Common Device Name: bronchoscope accessory
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Cork Limited; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50808916
• Report Number: 3005099803-2026-03840
• Device Sequence Number: 18291938
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: M00550350
• Device Catalogue Number: M00550350
• Device Lot Number: 0037383008
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 09/05/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 149 LB