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

Model Number	M00550340
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	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two cre pulmonary dilatation balloons used in the same patient and procedure.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, the balloon was inserted up to the stenosis part and inflated once.However, it could not be inflated during the second attempt.The procedure was performed again using another device from the same lot number; however, the same problem occurred, and inflation was not possible.The procedure was completed with the third cre pulmonary dilatation balloon.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation finding of a balloon pinhole.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable investigation result of balloon pinhole.Block h11: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was able to be inflated without any problem; however, it was not able to hold the pressure due to it had a pinhole in the balloon, located approximately at 44 mm from the tip of the device, which leads to the reported failure to inflate.Microscopic inspection confirmed the balloon pinhole.No other problems with the device were noted.The results of the analysis performed on the returned device found that the balloon had a pinhole located approximately at 44 mm from the tip of the device causing the balloon not to inflate.The pinhole found is likely to have 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 to 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.

• 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: 23834586
• Report Number: 3005099803-2025-06773
• Device Sequence Number: 9288337
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: (01)08714729456223(17)280702(10)36893780
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/17/2025

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: M00550340
• Device Catalogue Number: M00550340
• Device Lot Number: 0036893780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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