MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550340
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leak.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the trachea during an airway stenosis dilation procedure performed on (b)(6) 2026.During the procedure, the front end of the device was observed to be leaking water.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the trachea during an airway stenosis dilation procedure performed on (b)(6) 2026.During the procedure, the front end of the device was observed to be leaking water.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leak.Block h11: investigation results.The returned cre pulmonary dilatation balloon was analyzed.Visual inspection identified that the balloon was torn.A microscopic examination was performed and confirmed the presence of a tear in the balloon, resulting in a leak.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The analysis on the returned device found that the balloon tear directly contributed to the reported leak.It is possible that the leak found in the balloon occurred due to factors encountered during the procedure or it can be due to excess pressure.Also, it is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon and could have caused the pinhole found on the balloon.These factors and interactions could influence the damage found in the balloon.Therefore, the most probable root cause is adverse event related to procedure.Device history records review: 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.Risk review: a risk review was completed and confirmed that the event of balloon leak was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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 ; 9145716918
• MDR Report Key: 24338864
• Report Number: 3005099803-2026-00598
• Device Sequence Number: 15900264
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: (01)08714729456223(17)261211(10)33040875
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K170759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: M00550340
• Device Catalogue Number: M00550340
• Device Lot Number: 0033040875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 75 KG