MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	M00576490
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report 3005099803-2016-03620 and manufacturer report 3005099803-2016-03621 for the associated device information.It was reported to boston scientific corporation on november 03, 2016 that two ultraflex tracheobronchial stents were to be used in the lungs to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, both stents would not fully deploy.The partially deployed stents were removed from the patient and the procedure was completed with another ultraflex tracheobronchial stent.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.
Additional Manufacturer Narrative
Investigation results: a fully-deployed ultraflex tracheobronchial delivery system was returned for analysis, and the stent was not returned.Visual examination of the returned device noted that there was no issue with the device shaft.No other issues were identified during the product analysis.The investigation was unable to confirm the reported event based on the condition of the returned device because the device was returned fully deployed and without the stent.A review and analysis of all available information indicated that the cause of the reported deployment difficulties was most probably due to anatomical or procedural factors encountered during the procedure.Therefore, the most probable root cause for this complaint is operational context.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report 3005099803-2016-03620 and manufacturer report 3005099803-2016-03621 for the associated device information.It was reported to boston scientific corporation on november 03, 2016 that two ultraflex tracheobronchial stents were to be used in the lungs to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, both stents would not fully deploy.The partially deployed stents were removed from the patient and the procedure was completed with another ultraflex tracheobronchial stent.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.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6130300
• Report Number: 3005099803-2016-03620
• Device Sequence Number: 211865
• Product Code: JCT
• UDI-Device Identifier: 08714729837855
• UDI-Public: (01)08714729837855(17)20180112(10)18799047
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121048
• 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,Followup
• Report Date (Section B): 11/03/2016

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: 01/12/2018
• Device Model Number: M00576490
• Device Lot Number: 18799047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1