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

Model Number	M00576410
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2017
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).Although the suspect device has been received, 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on january 11, 2017 that an ultraflex¿ tracheobronchial stent was to be implanted in the right middle lobe stem during a stent placement procedure performed on (b)(6) 2017.Reportedly, there were two non-bsc stents that were implanted in the site.According to the complainant, when the physician started deploying the stent, the catheter bowed and the stent was deployed inadvertently distal from the stricture.The stent knocked out the two non-bsc stents.The physician removed the three stents and the procedure was completed 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.
Additional Manufacturer Narrative
A fully expanded ultraflex tracheobronchial stent was returned for analysis.The delivery system was not returned for analysis.The stent was measured to be 19.5 mm in length and 7.3 mm in outer diameter which is within specification.No issues were identified during the product analysis.The investigation could not confirm the reported event based on the condition of the returned device.However, taking all available information into consideration, the investigation concluded that the reported event was most probably 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 review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation on january 11, 2017 that an ultraflex¿ tracheobronchial stent was to be implanted in the right middle lobe stem during a stent placement procedure performed on (b)(6) 2017.Reportedly, there were two non-bsc stents that were implanted in the site.According to the complainant, when the physician started deploying the stent, the catheter bowed and the stent was deployed inadvertently distal from the stricture.The stent knocked out the two non-bsc stents.The physician removed the three stents and the procedure was completed 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.

• Brand Name: ULTRAFLEX¿ TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6290656
• Report Number: 3005099803-2017-00262
• Device Sequence Number: 1036997
• Product Code: JCT
• UDI-Device Identifier: 08714729837770
• UDI-Public: (01)08714729837770(17)20180808(10)0019566259
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/11/2017

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: 08/08/2018
• Device Model Number: M00576410
• Device Lot Number: 0019566259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/06/2017
• 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
• Patient Weight: 107