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	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation balloon was used in the trachea during a balloon dilatation procedure to treat airway stenosis performed on (b)(6) 2025.During the procedure, a balloon dilatation was performed to a patient because of an airway stenosis.It was reported that the balloon burst in the trachea when it was inflated at 5 atmospheric pressure and with the handle specially used by boston scientific (bsc).No piece of the balloon detached inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a cre pulmonary dilatation balloon was used in the trachea during a balloon dilatation procedure to treat airway stenosis performed on (b)(6) 2025.During the procedure, a balloon dilatation was performed to a patient because of an airway stenosis.It was reported that the balloon burst in the trachea when it was inflated at 5 atmospheric pressure and with the handle specially used by boston scientific (bsc).No piece of the balloon detached inside the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
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 that balloon portion was mechanically cut off and it was not returned.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was unable to be confirmed.The returned device was not returned with the balloon portion that had evidence of a mechanical cut in the catheter.The mechanical cut found in the device occurred due to procedural factors and the manner in which the device was handled and manipulated may have caused the encountered problems.Excessive manipulation of the device without enough care could have induced the problem found.Therefore, the most probable root cause is an adverse event related to procedure.

• 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 CORPORATION; 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: 23280149
• Report Number: 3005099803-2025-05190
• Device Sequence Number: 8762258
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: (01)08714729456230(17)270819(10)34666046
• 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): 12/22/2025

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: 0034666046
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG