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

Model Number	M00550310
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, it was noticed that the pressure of the dilator syringe was not holding.The balloon was tested on the table after the procedure and a hole was noticed at the tip.A photo of the complaint device was provided and shows the balloon inflated outside the patient with a pinhole leak of liquid streaming from the distal end of the balloon.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 have fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole.Block h11: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual examination found that the balloon had no damages.Media analysis was performed and with evidence showing pinhole in the balloon.Functional and microscopic inspection were performed, and the balloon was inflated without any problem; however, it was not able to hold pressure due to a pinhole in the balloon, which produces a failure to inflate.The pinhole was located approximately 16mm from the tip.No other problems with the device were noted.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of " balloon pinhole" 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.With all the available information, boston scientific concludes the reported event of balloon pinhole was confirmed.The analysis on the returned device found that the balloon had a pinhole located approximately at 16 mm from the tip of the device.It is possible that the pinhole 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.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, it was noticed that the pressure of the dilator syringe was not holding.The balloon was tested on the table after the procedure and a hole was noticed at the tip.A photo of the complaint device was provided and shows the balloon inflated outside the patient with a pinhole leak of liquid streaming from the distal end of the balloon.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 have fully recovered.

• 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: 24206887
• Report Number: 3005099803-2026-00349
• Device Sequence Number: 14826450
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: (01)08714729456193(17)280501(10)36428648
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: M00550310
• Device Catalogue Number: M00550310
• Device Lot Number: 0036428648
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2025
• 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 Sex: Unknown