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

Model Number	M00576560
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported to boston scientific corporation on may 27, 2022 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant intrinsic tumor in the left main stem bronchus during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the physician applied a lot of force to deploy the ultraflex stent.The stent was fully deployed but, a portion of the stent was lodged in the endotracheal (et) tube.The et tube along with the stent were removed completely.The patient was re-intubated and the procedure was completed with another ultraflex tracheobronchial stent.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: 14737353
• Report Number: 3005099803-2022-03308
• Device Sequence Number: 11316154
• Product Code: JCT
• UDI-Device Identifier: 08714729842361
• UDI-Public: 08714729842361
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 06/17/2022

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: 03/30/2024
• Device Model Number: M00576560
• Device Catalogue Number: 7656
• Device Lot Number: 0029141972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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: Female
• Patient Race: Black Or African American