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

Model Number	M00576430
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex tracheobronchial sterile uncovered proximal release stent was to be used to treat a malignant subcarinal stenosis during a bronchoscopy with stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s airway was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the physician started deploying the stent, however, the stent deployment suture broke near the distal tip.The partially deployed stent was removed from the patient and the procedure was not completed as the same device was unavailable.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion was reported to be fine.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7114331
• Report Number: 3005099803-2017-03716
• Device Sequence Number: 1351574
• Product Code: JCT
• UDI-Device Identifier: 08714729837794
• UDI-Public: 08714729837794
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/20/2017

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: 07/31/2019
• Device Model Number: M00576430
• Device Lot Number: 20947993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1