MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	M00576530
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on december 30, 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture in the left bronchus during an airway stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, the stent was positioned in the left bronchus towards the left lower lobe.During deployment, the pull string got "hung up" and the stent was difficult to deploy.The delivery system was adjusted to make the string more fluid to release and deployment was restarted several times with the deployment string getting hung up several times.Towards the end of deployment, the delivery catheter bowed and the stent suddenly deployed in an incorrect location.The stent was removed with forceps and another ultraflex tracheobronchial stent was placed to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2019 that an ultraflex tracheobronchial covered distal release stent was to be used to treat a malignant stricture in the left bronchus during an airway stent placement procedure performed on (b)(6), 2019.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, the stent was positioned in the left bronchus towards the left lower lobe.During deployment, the pull string got "hung up" and the stent was difficult to deploy.The delivery system was adjusted to make the string more fluid to release and deployment was restarted several times with the deployment string getting hung up several times.Towards the end of deployment, the delivery catheter bowed and the stent suddenly deployed in an incorrect location.The stent was removed with forceps and another ultraflex tracheobronchial stent was placed to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 3009 captures the reportable event of stent positioning issue.Block h10: an ultraflex tracheobronchial delivery system, deployment suture and finger ring were received for analysis; the stent was not returned.Visual examination of the returned device found the shaft was kinked approximately 30mm from the tip of the delivery system.No other issues with device were noted.The reported event f stent positioning issue is unable to be confirmed, however, the report that the delivery catheter bowed is confirmed, as the noted kink in the shaft upon analysis could have been caused by the bowing.The damage noted on the delivery system may have been a result of how the device was handled or manipulated, or that the margins were not been centered correctly between the delivery system ro markers during use, or the number of times the user attempted to deploy the stent, and the amount of strength applied to the device, and/or the interaction between the scope and the device during the procedure, which limited the performance of the device therefore, the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/ product label.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9616375
• Report Number: 3005099803-2020-00072
• Device Sequence Number: 2721284
• Product Code: JCT
• UDI-Device Identifier: 08714729842330
• UDI-Public: 08714729842330
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 03/05/2020

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: 09/26/2021
• Device Model Number: M00576530
• Device Catalogue Number: 7653
• Device Lot Number: 0024502752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/05/2020
• 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