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

Model Number	M00576530
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Unraveled Material (1664); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant stricture in the left main stem of the lung during a tracheobronchial stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent was misdeployed and the stent location could not be confirmed under live fluoroscopy due to anatomical or procedural circumstances.During removal of the delivery system, the stent was dislodged into the trachea.The stent was removed from the patient with forceps.During removal of the stent, the stent was unraveled and the stent suture was broken.The procedure was not completed due to availability of the device.There were no patient complications reported due to this event.A photo provided by the complainant of the device outside the patient showed the stent was unraveled and the stent suture was broken.
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 13396780
• Report Number: 3005099803-2022-00329
• Device Sequence Number: 3895668
• Product Code: JCT
• UDI-Device Identifier: 08714729842330
• UDI-Public: 08714729842330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2022

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 Expiration Date: 08/17/2023
• Device Model Number: M00576530
• Device Catalogue Number: 7653
• Device Lot Number: 0027850499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: Black Or African American