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

Model Number	M00576310
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2016 that an ultraflex tracheobronchial distal release uncovered stent was to be used in the bronchus during an airway stent placement procedure performed on (b)(6) 2016.Reportedly, patient¿s anatomy was not tortuous.According to the complainant, during the procedure, the physician started deploying the stent when the deployment suture got stuck and the catheter bowed.The partially deployed stent was 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 fine.
Additional Manufacturer Narrative
Investigation results: an ultraflex tracheobronchial s:tent delivery system was returned for analysis.The delivery system was fully-deployed and the stent was not returned.Visual evaluation found the device shaft was kinked.No other issues were noted with the device.Based on the condition of the returned device, the reported event could not be confirmed.However, the investigation concluded 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.
Event or Problem Description
It was reported to boston scientific corporation on november 14, 2016 that an ultraflex tracheobronchial distal release uncovered stent was to be used in the bronchus during an airway stent placement procedure performed on (b)(6) 2016.Reportedly, patient¿s anatomy was not tortuous.According to the complainant, during the procedure, the physician started deploying the stent when the deployment suture got stuck and the catheter bowed.The partially deployed stent was 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 fine.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6152493
• Report Number: 3005099803-2016-03727
• Device Sequence Number: 10981977
• Product Code: JCT
• UDI-Device Identifier: 08714729837695
• UDI-Public: (01)08714729837695(17)20180630(10)0019431761
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/14/2016

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: 06/30/2018
• Device Model Number: M00576310
• Device Lot Number: 0019431761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 82