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

Model Number	M00550310
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.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 trachea during a balloon dilatation of the airway procedure performed on (b)(6) 2025.During the procedure, laryngeal mask anesthesia was used during excision of the tracheal lesion and perform balloon dilation.However, during the procedure, the balloon was found to be leaking.It was reported that water was injected with a syringe for pressurization.Despite the excessive injection volume, the pressure gauge failed to maintain stability at the first-level pressure.The operator withdrew the balloon from the stenotic site, observed the balloon was leaking, and then identified the balloon ruptured.No piece of the balloon detached inside the patient.Due to the problem of the balloon dilatation step, the physician switched to using a biopsy forceps to resect the hyperplastic tissue, thereby widening the airway and completed the procedure.The change in surgical approach has resulted in the prolongation of the operation time and was estimated to be extended by 30 minutes.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 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23323859
• Report Number: 3005099803-2025-05397
• Device Sequence Number: 15930180
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: (01)08714729456193(17)261112(10)32838184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/17/2025

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: M00550310
• Device Catalogue Number: M00550310
• Device Lot Number: 0032838184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Date Device Manufactured: 11/13/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG