MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE Pulmonary; bronchoscope accessory

Model Number	M00550350
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary dilatation balloon was used in the right lower lobe of the lung during a bronchial dilation procedure to treat airway stenosis performed on (b)(6) 2026.During the procedure, it was reported that the balloon portion of the balloon catheter detached from the catheter while inflated.The technician indicates that they had to retrieve the balloon after they removed the catheter with a forceps.The procedure was completed with original device.There were no patient complications reported as a result of this event and the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0501 captures the reportable event of balloon detached.Imdrf impact code f2301 captures the reportable event of additional device required.(forceps used to retrieve the detached balloon).Block h11: investigation results.The device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.However, media analysis was performed and found that the distal portion of the balloon was observed detached.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event of balloon detached was confirmed.The device was not returned for analysis because it was disposed.The customer provided a picture where it was possible to observe that the distal portion of the balloon was detached.The balloon detached found is likely to have occurred due to the manner the device was handled and manipulated.Excessive manipulation of the device without enough care could have induced the problem found.Based on all gathered information, the most probable root cause is adverse event related to procedure.The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.A similar complaint review was completed.There were no emerging trends identified that warrant further action.

• 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 ; +1(914)571-6918
• MDR Report Key: 50625949
• Report Number: 3005099803-2026-03649
• Device Sequence Number: 21498540
• Product Code: KTI
• UDI-Device Identifier: 08714729456230
• UDI-Public: (01)08714729456230(17)280902(10)37359314
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00550350
• Device Catalogue Number: M00550350
• Device Lot Number: 0037359314
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/05/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 09/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown