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

Model Number	M00576570
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
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 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
Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # (b)(4) for the associated device information.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 stricture during a bronchoscopy with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during the procedure, the ultraflex tracheobronchial stent (the subject of this report) was attempted to be deployed; however, the shaft bowed and the stent was pulled proximally and no longer centered in stricture.The stent was removed from the patient partially deployed on the delivery system.Reportedly, another ultraflex tracheobronchial stent of different size (the subject of mfr.Report # (b)(4)) was used, however, the same problem occurred.The shaft bowed during attempted deployment and the stent was partially deployed on the delivery system when removed from the patient.Reportedly, the procedure was not completed as another stent of the same size was unavailable.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
• MDR Report Key: 10906532
• Report Number: 3005099803-2020-05601
• Device Sequence Number: 3230719
• Product Code: JCT
• UDI-Device Identifier: 08714729842378
• UDI-Public: 08714729842378
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/25/2020

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: 10/22/2021
• Device Model Number: M00576570
• Device Catalogue Number: 7657
• Device Lot Number: 0024643347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1