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

Model Number	M00550310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block g4: the remaining premarket/510(k) number is k170759; reported here as premarket/510(k) number exceeded the character limit for the designated field.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the throat during a tracheoscopy with balloon dilatation procedure performed on (b)(6) 2025.During the procedure, a leak was noticed in the cre balloon during inflation.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the throat during a tracheoscopy with balloon dilatation procedure performed on (b)(6) 2025.During the procedure, a leak was noticed in the cre balloon during inflation.The procedure was completed with another cre pulmonary dilatation balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g4: the remaining premarket/510(k) number is k170759; reported here as premarket/510(k) number exceeded the character limit for the designated field.Block h6: imdrf device code a0504 captures the reportable event of a balloon leak.Block h11: investigation results the returned cre pulmonary dilatation balloon was analyzed, and a visual examination found that the balloon had no damages.Functional and microscopic inspection was performed, 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 leak, located approximately 84 mm from the tip.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The analysis on the returned device found that the balloon had a pinhole located approximately at 84 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 or interaction with other devices.Also, it is possible that interaction with a sharp surface during/previous the procedure, could have caused the pinhole found on the balloon.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 23186964
• Report Number: 3005099803-2025-05012
• Device Sequence Number: 9815169
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: (01)08714729456193(17)280423(10)36363534
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: K023337
• 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): 12/04/2025

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: M00550310
• Device Catalogue Number: M00550310
• Device Lot Number: 0036363534
• 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: 09/08/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2025
• 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: 81 YR
• Patient Sex: Female