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

Model Number	M00576560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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
It was reported to boston scientific corporation on (b)(6) 2017 that an ultraflex tracheobronchial distal release stent was used to treat a 4 to 5 cm malignant stricture in the trachea during a bronchoscopy with stent placement procedure performed on (b)(6) 2017.Reported, the patient's anatomy was narrowed and had been dilated twice prior to stent placement: from 8 mm to 10 mm with a pulmonary dilatation balloon then 10 mm to 12 mm with a second pulmonary dilatation balloon.According to the complainant, during the procedure, the physician was able to deploy the stent at the correct anatomy location.However, during the removal of the scope, the physician noted that there was a sharp piece sticking out of the proximal end of the stent.The fully deployed stent was removed using rat tooth forceps and was examined by the physician under a microscope.The microscopic examination performed by the physician confirmed the damage noted on the proximal end of the stent upon scope withdrawal.The procedure was completed with a different device.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: 6771680
• Report Number: 3005099803-2017-02309
• Device Sequence Number: 13857016
• Product Code: JCT
• UDI-Device Identifier: 08714729842361
• UDI-Public: (01)08714729842361(17)20191205(10)20635413
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/12/2019
• Device Model Number: M00576560
• Device Lot Number: 20635413
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention