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

Model Number	M00550340
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
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 in the right main trachea.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was attempted to be used in the right main trachea during a transbronchoscopic balloon dilatation procedure performed on (b)(6) 2025.During procedure, after unpacking, the balloon dilatation catheter entered the tracheal stenosis position through the working channel of the fiberoptic bronchoscope, and it was found that the device leaked water after dilatation.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 after the procedure was reported to be stable.
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 in the right main trachea.Block h11: investigation results, the returned cre pulmonary dilatation balloon was analyzed, and a visual evaluation found the balloon was longitudinally torn.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon leak was confirmed.The returned device revealed it was longitudinally torn which produced a leak.It is possible that the longitudinal tear found on the balloon occurred due to procedural factors such as excess pressure or interaction with other devices, or anatomical factors.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the balloon tear.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 in the right main trachea during a transbronchoscopic balloon dilatation procedure performed on (b)(6) 2025.During procedure, after unpacking, the balloon dilatation catheter entered the tracheal stenosis position through the working channel of the fiberoptic bronchoscope, and it was found that the device leaked water after dilatation.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 after the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21731418
• Report Number: 3005099803-2025-01206
• Device Sequence Number: 9002111
• Product Code: KTI
• UDI-Device Identifier: 08714729456223
• UDI-Public: (01)08714729456223(17)270822(10)34694882
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/04/2025

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: M00550340
• Device Catalogue Number: M00550340
• Device Lot Number: 0034694882
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 55 KG