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

Model Number	M00576310
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however 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 medwatch will be filed.
Event or Problem Description
It was noted by boston scientific corporation on (b)(6) 2018 that an ultraflex tracheobronchial uncovered distal release stent was to be used to treat a 7.1 x 8.8 cm malignant tumor in the right upper lobe during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was dilated prior to stent placement.According to the complainant, during the procedure, there was difficulty deploying the stent inside the patient.The physician pulled the stent deployment suture to release the stent but noted that the stent was pulled back along with it.Eventually, the stent deployment suture fully released, and the stent was deployed inside the patient, but not in the target location.The stent was removed with forceps and another ultraflex tracheobronchial stent was placed to complete the procedure.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 stable.
Event or Problem Description
It was noted by boston scientific corporation on june 27, 2018 that an ultraflex tracheobronchial uncovered distal release stent was to be used to treat a 7.1 x 8.8 cm malignant tumor in the right upper lobe during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was dilated prior to stent placement.According to the complainant, during the procedure, there was difficulty deploying the stent inside the patient.The physician pulled the stent deployment suture to release the stent but noted that the stent was pulled back along with it.Eventually, the stent deployment suture fully released, and the stent was deployed inside the patient, but not in the target location.The stent was removed with forceps and another ultraflex tracheobronchial stent was placed to complete the procedure.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 stable.
Additional Manufacturer Narrative
An ultraflex tracheobronchial uncovered distal release stent was received for analysis; the delivery system was not returned.The stent was received deployed and expanded.Visual examination identified no issues with the stent.The green retention suture in both sides were inspected and no anomalies were noted.The stent was measured to be within specifications.Taking all available information into consideration, the investigation concluded that the reported failures were likely due to anatomical or procedural factors encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.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 search of the complaint database confirmed that no other similar complaints exist for the specified lot.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7703783
• Report Number: 3005099803-2018-02301
• Device Sequence Number: 19015731
• Product Code: JCT
• UDI-Device Identifier: 08714729837695
• UDI-Public: 08714729837695
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/27/2018

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 Expiration Date: 11/14/2018
• Device Model Number: M00576310
• Device Lot Number: 0019961427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/30/2018
• 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
• Patient Age: 63 YR
• Patient Weight: 19