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

Model Number	M00576470
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event of stent partially deployed.The complainant indicated that the device has been 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 manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report # 3005099803-2016-03497 and 3005099803-2016-03597 for the other associated device information.It was reported to boston scientific corporation on november 1, 2016 that two ultraflex tracheobronchial stents were to be used in the right mainstem bronchus during a bronchoscopy with stent placement procedure performed on (b)(6) 2016.According to the complainant, the physician started deploying the first ultraflex tracheobronchial stent (the subject to mfr report # 3005099803-2016-03497) when the stent could not be fully deployed and the catheter bowed.The partially deployed stent was removed from the patient.The physician used a second ultraflex tracheobronchial stent (the subject to mfr report # 3005099803-2016-03597); however, the stent still could not be fully deployed.During removal of the partially deployed stent, the stent system got stuck in the patient¿s endotracheal tube.The physician removed the endotracheal tube and reintubated the patient.Reportedly, another ultraflex tracheobronchial stent was implanted one week post-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 fine.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6122131
• Report Number: 3005099803-2016-03497
• Device Sequence Number: 16412769
• Product Code: JCT
• UDI-Device Identifier: 08714729837831
• UDI-Public: (01)08714729837831(17)20170511(10)0017979308
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 11/01/2016

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: 05/11/2017
• Device Model Number: M00576470
• Device Lot Number: 0017979308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1