MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX? TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	M00576380
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to january 01, 2025; no specific event date was reported.Block h6: device code a0501 captures the reportable event of tip detached.Block h11: an ultraflex tracheobronchial distal release covered stent and delivery system were received for analysis.Visual examination of the returned device found the stent fully covered and undeployed; and the suture was found detached.In addition, the tip of the device was not returned, it detached.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported event of device damaged/defective as the tip of the stent was detached.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors as lesion characteristics, handling of the device and the technique used by the physician (force applied).Therefore, the most probable cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was to be implanted during an unspecified procedure performed on an unknown date.It was reported that the device was found defective before the procedure.There were no patient complications as a result of this event.No further information has been obtained despite good faith efforts.Noted: this event has been deemed an mdr-reportable event based on investigation results, which revealed that the tip was detached.Please see block h11 for full investigation details.

• Brand Name: ULTRAFLEX? TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22187147
• Report Number: 3005099803-2025-02679
• Device Sequence Number: 18285219
• Product Code: JCT
• UDI-Device Identifier: 08714729837763
• UDI-Public: (01)08714729837763(17)251212(10)33046068
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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 Expiration Date: 12/12/2025
• Device Model Number: M00576380
• Device Catalogue Number: M00576380
• Device Lot Number: 0033046068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown