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

Model Number	M00576610
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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 (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant neoplasm in the distal trachea during a tracheobronchial airway stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was slightly tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed and the delivery system was successfully removed from the patient.Reportedly, the physician introduced the bronchoscope to check for stent placement and it was noted that the distal portion of the stent did not fully expand; the nitinol loops bent inwards.The physician attempted to adjust the stent by pulling the stent both proximally and distally with rat-toothed grasping forceps, but the stent did not fully expand at the distal end.The stent was removed with rat- toothed forceps and a different stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and fine.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10171187
• Report Number: 3005099803-2020-02375
• Device Sequence Number: 2142821
• Product Code: JCT
• UDI-Device Identifier: 08714729842415
• UDI-Public: 08714729842415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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: 01/20/2022
• Device Model Number: M00576610
• Device Catalogue Number: 7661
• Device Lot Number: 0025074167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention