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

Model Number	M00576550
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.We've sent good faith effort attempts to obtain all missing information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent positioning issue.The device has not been returned for product evaluation as it was disposed; therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a device malfunction.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the complaint device was not returned for evaluation as the device was disposed; therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the events of stent positioning issue and additional device required were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was attempted to be implanted to the lungs to treat a stricture caused by cancer during a bronchoscopy procedure performed on (b)(6) 2026.The anatomy of the patient was torturous.During the procedure, when the scope was retracted, the physician felt resistance.Upon inspection through the scope, it was observed that the stent was caught on the endotracheal tube.Reportedly, the stent was difficult to be removed but it was eventually retrieved by using forceps.The procedure was completed using another of the same device.There are no patient complications reported as result of the procedure.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25399410
• Report Number: 3005099803-2026-02316
• Device Sequence Number: 10718443
• Product Code: JCT
• UDI-Device Identifier: 08714729842354
• UDI-Public: (01)08714729842354
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141584
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: M00576550
• Device Catalogue Number: M00576550
• 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: 05/08/2026
• Initial Report FDA Received Date: 06/04/2026
• 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