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

Model Number	M00576690
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).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
It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a stricture in the airway due to tracheobronchomalacia during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, the stent was placed in an incorrect location, and the stent appeared folded under fluoroscopic view.The stent was removed with forceps.The physician rescheduled the procedure on the following day, and completed it 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.The complainant reported that they compared the delivery system of the complaint device with the delivery system of the device successfully used to complete the procedure and noted that the distance from the distal ro marker to the dilation tip of the device was longer on the complainant delivery system.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7616131
• Report Number: 3005099803-2018-02045
• Device Sequence Number: 2129722
• Product Code: JCT
• UDI-Device Identifier: 08714729842491
• UDI-Public: 08714729842491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/25/2018

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 Model Number: M00576690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• 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