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

Model Number	M00576560
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of partially deployed ultraflex tracheobronchial stent.
Event or Problem Description
It was reported to boston scientific corporation on june 13, 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted in the left main bronchus to treat a 2 cm malignant stricture due to cancer in the esophagus during a bronchial metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the ultraflex tracheobronchial stent could only be partially released after pulling the deployment suture.The stent was removed from the patient partially deployed on the delivery system, and a different stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 17248846
• Report Number: 3005099803-2023-03611
• Device Sequence Number: 4795276
• Product Code: JCT
• UDI-Device Identifier: 08714729842361
• UDI-Public: 08714729842361
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2023

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: 07/22/2023
• Device Model Number: M00576560
• Device Catalogue Number: 7656
• Device Lot Number: 0027712222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: 75 YR
• Patient Sex: Unknown