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

Model Number	M00550310
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was being prepared to be used in the upper airway during a microlaryngoscopy procedure for dilation performed on (b)(6) 2026.During preparation, it was found that there was a pinhole in the balloon.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of balloon pinhole.Block h11: the returned cre pulmonary dilatation balloon device was analyzed, and a visual inspection found no damages.A functional inspection was performed, and the balloon was inflated without any problem; however, it was not able to hold the pressure due to a pinhole in the balloon located approximately at 80 mm from the tip of the device.Microscope inspection confirmed the presence of 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 results of the analysis performed on the returned device found that the balloon was inflated without any problem; however, it was not able to hold the pressure due to a pinhole in the balloon located approximately at 80 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/previous the procedure, could have caused the failure found on the distal section of the balloon.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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.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.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was being prepared to be used in the upper airway during a microlaryngoscopy procedure for dilation performed on (b)(6) 2026.During preparation, it was found that there was a pinhole in the balloon.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.

• 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: 24534603
• Report Number: 3005099803-2026-00859
• Device Sequence Number: 8894978
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: (01)08714729456193(17)271016(10)35076545
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2026

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: 0035076545
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2024
• 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 Sex: Unknown