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

Model Number	M00576550
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release covered stent was to be implanted in the airway during a bronchoscopy with stent implantation procedure performed on (b)(6) 2024.During the procedure, the stent deployment suture got stuck and the stent could not be fully deployed.The stent was removed from the patient partially deployed and another ultraflex tracheobronchial stent was used to complete the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block b5 has been updated based on the additional information received on october 28, 2024.Block d4 (catalog number) was corrected.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial distal release covered stent was to be implanted in the airway during a bronchoscopy with stent implantation procedure performed on (b)(6) 2024.During the procedure, the stent deployment suture got stuck and the stent could not be fully deployed.The stent was removed from the patient partially deployed and another ultraflex tracheobronchial stent was used to complete the procedure.No patient complications were reported as a result of this event.Additional information received on october 28, 2024.It was reported that the stent was to be implanted in the lung due to malignancy.The patient's anatomy was not tortuous.

• 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: 20467454
• Report Number: 3005099803-2024-05223
• Device Sequence Number: 7236213
• Product Code: JCT
• UDI-Device Identifier: 08714729842354
• UDI-Public: 08714729842354
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 06/11/2025
• Device Model Number: M00576550
• Device Catalogue Number: 7655
• Device Lot Number: 0031801310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/21/2024
• Date Device Manufactured: 06/12/2023
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 66 KG