MAUDE Adverse Event Report: SEWOON MEDICAL CO., LTD. BONASTENT® TRACHEAL/BRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	BTB-140309
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Tracheobronchial stent did not deploy.

• Brand Name: BONASTENT® TRACHEAL/BRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): SEWOON MEDICAL CO., LTD.; 5485 rathdrum way; antioch CA 94531
• MDR Report Key: 22929650
• Report Number: 22929650
• Device Sequence Number: 10231068
• Product Code: JCT
• UDI-Device Identifier: 08806369468602
• UDI-Public: (01)08806369468602(17)250725(10)220726
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 07/10/2025

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
• Device Model Number: BTB-140309
• Device Lot Number: 220726
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/10/2025