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

Model Number	M00576560
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the healthcare facility name is (b)(6) hospital.Block h6: imdrf device code a15 captures the reportable event of a stent's partial deployment.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial stent was to be implanted in the bronchus intermedius during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous prior to stent placement.During the procedure, the physician attempted to deploy the stent by pulling the suture with excessive force, but the stent could not be deployed.The stent was then removed from the patient, and the first two sutures were manually unraveled.The partially deployed stent was put back into the patient to attempt full deployment, but it could still not be deployed using excessive force.A non-boston scientific stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the first two sutures were manually unraveled and the stent was put back inside the patient to attempt full deployment.Per the instructions for use (ifu), "warning: do not attempt to reload a deployed or partially deployed stent." the user did not follow the steps of the ifu.

• 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: 18631075
• Report Number: 3005099803-2024-00253
• Device Sequence Number: 18131205
• Product Code: JCT
• UDI-Device Identifier: 08714729842361
• UDI-Public: 08714729842361
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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: 11/24/2024
• Device Model Number: M00576560
• Device Catalogue Number: 56598
• Device Lot Number: 0030602206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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: Unknown