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

Model Number	M00550350
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: the patient's specific date of birth is unknown; however, it was reported that the patient was born on 1953.E1: initial reporter facility name is (b)(6).It is reported here as initial reporter facility name exceeded the character limit for the designated field.H6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the left main bronchus during a bronchoscopic balloon dilation procedure to treat bronchial stenosis performed on (b)(6) 2025.During the procedure, bronchoscopic balloon dilatation was performed 10 minutes after ablation, and the balloon burst when it was filled to its maximum diameter.It was reported that no piece of the balloon detached inside the patient.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 left main bronchus during a bronchoscopic balloon dilation procedure to treat bronchial stenosis performed on (b)(6) 2025.During the procedure, bronchoscopic balloon dilatation was performed 10 minutes after ablation, and the balloon burst when it was filled to its maximum diameter.It was reported that no piece of the balloon detached inside the patient.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 a2: the patient's specific date of birth is unknown; however, it was reported that the patient was born on 1953.(b)(6).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h11: investigation results: the returned cre pulmonary dilatation balloon was analyzed and a visual inspection found no physical damage.A functional evaluation found the balloon inflated without problem but was not able to hold pressure due to pinholes in the balloon, located approximately at 51 mm from the tip of the device.Microscopic evaluation found the balloon had pinholes.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon burst was not confirmed.The returned device was inflated without any problem however it was not able to hold pressure due to pinholes located approximately 51 mm from the tip of the device.The pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.It is possible that the pinhole found on the balloon occurred due to procedural factors such as excess pressure or interaction with other devices, or anatomical factors.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the balloon pinhole.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of balloon burst 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: 22835120
• Report Number: 3005099803-2025-03988
• Device Sequence Number: 9838292
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: (01)08714729456230(17)280325(10)36155131
• 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): 04/08/2026

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: 0036155131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 03/26/2025
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: Asian