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

Model Number	M00576580
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf device code a0501 captures the reportable event of tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release stent was to be implanted in the airway for palliative treatment during a tracheobronchial (tb) stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent did not deploy correctly.The stent was removed from the patient, and a different stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a review of the provided photo of the complaint device revealed that the stent was partially deployed on the delivery system, the shaft appeared kinked, and the tip was noted to be detached.
Additional Manufacturer Narrative
Block b5 was updated based on the additional information received on march 19, 2024.Imdrf device code a15 captures the reportable event of stent partially deployed.Imdrf device code a0501 captures the reportable event of tip detachment of device or device component.An ultraflex tracheobronchial stent was received for analysis.Visual examination of the returned device found the stent was partially deployed.Additionally, the shaft was noted to be kinked and the tip was not returned as it was detached.Functional inspection was performed by pulling the finger ring and no resistance was felt.No other problems were noted to the stent.Product analysis confirmed the reported events of stent partially deployed, shaft kinked, and tip detachment.It is most likely that procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied), limited the performance of the device and contributed to the observed failures.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release stent was to be implanted in the airway for palliative treatment during a tracheobronchial (tb) stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent did not deploy correctly.The stent was removed from the patient, and a different stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a review of the provided photo of the complaint device revealed that the stent was partially deployed on the delivery system, the shaft appeared kinked, and the tip was noted to be detached.***additional information received on march 19, 2024*** in the physician's assessment, the tip of the device was detached outside the patient.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18841667
• Report Number: 3005099803-2024-00789
• Device Sequence Number: 15317832
• Product Code: JCT
• UDI-Device Identifier: 08714729842385
• UDI-Public: 08714729842385
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 04/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/26/2024
• Device Model Number: M00576580
• Device Catalogue Number: 56598
• Device Lot Number: 0029486080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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
• Patient Sex: Male
• Patient Race: White