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

Model Number	BTB-100309
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per physician and tech, the deployment sheath bunched up.

• 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: 19104360
• Report Number: 19104360
• Device Sequence Number: 20775007
• Product Code: JCT
• UDI-Device Identifier: 08806369468121
• UDI-Public: (01)08806369468121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/25/2024
• Report Date (Section F): 03/25/2024

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-100309
• Device Lot Number: 230727
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Race: White
• Date Report Sent to FDA: 03/25/2024