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

Model Number	M00550340
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the lungs.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left upper lobe of the lungs during a balloon dilatation procedure to treat bronchial stenosis performed on (b)(6) 2025.During the procedure, a leak was found at the connection between the purple plastic at the proximal end of the balloon and the balloon.It was reported that a visible pinhole was noted in the balloon.The procedure was completed with another of the same device.Photos of the complaint device outside the patient were provided by the customer and show a water leak at the purple plastic on the proximal end of the balloon.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.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left upper lobe of the lungs during a balloon dilatation procedure to treat bronchial stenosis performed on (b)(6) 2025.During the procedure, a leak was found at the connection between the purple plastic at the proximal end of the balloon and the balloon.It was reported that a visible pinhole was noted in the balloon.The procedure was completed with another of the same device.Photos of the complaint device outside the patient were provided by the customer and show a water leak at the purple plastic on the proximal end of the balloon.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 e1: the initial reporter facility name is (b)(6) hospital; reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the lungs.Block h11: media inspection of the photo provided by the customer found it was possible to observe the balloon had a pinhole.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon pinhole was confirmed.The product analysis could not be performed because the device was not returned.However, the photo provided by the customer shows the device with evidence of balloon pinhole.Without analysis of the device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.Therefore, the most probable root cause could not be established.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the left upper lobe of the lungs during a balloon dilatation procedure to treat bronchial stenosis performed on (b)(6) 2025.During the procedure, a leak was found at the connection between the purple plastic at the proximal end of the balloon and the balloon.It was reported that a visible pinhole was noted in the balloon.The procedure was completed with another of the same device.Photos of the complaint device outside the patient were provided by the customer and show a water leak at the purple plastic on the proximal end of the balloon.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 e1: the initial reporter facility name is (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole in the lungs.Block h11: investigation results: the returned cre pulmonary dilatation balloon was analyzed, and a visual inspection found no physical damage on the device.Functional inspection found that the balloon was inflated without any problem; however, it was not able to hold the pressure due to it had a pinhole in the catheter, located approximately at 54 mm from the tip of the device.Microscopic and media inspection shows evidence of pinhole.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon pinhole was confirmed.The returned balloon was found to have a pinhole located approximately at 54 mm from the tip of the device.It is possible that the pinhole found in the balloon occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an 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.

• 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: 23640189
• Report Number: 3005099803-2025-06128
• Device Sequence Number: 13039537
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: (01)08714729456223(17)280414(10)36302651
• 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,Followup
• Report Date (Section B): 04/07/2026

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: 0036302651
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 03/12/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/17/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2025
• 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: 60 YR
• Patient Sex: Male