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

Model Number	M00576580
Medical Device Problem Codes	Premature Activation (1484); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on april 15, 2019 that an ultraflex tracheobronchial covered distal release stent was used during an airway stent implantation procedure performed on (b)(6) 2019.According to the complainant, during stent deployment, the delivery system bent and the stent was deployed into the wrong lung.The physician had to extubate to remove the stent from the patient.Reportedly, the case was completed with no patient complications.Despite numerous attempts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
(b)(4).An ultraflex tracheobronchial covered distal release stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received deployed, unraveled and expanded.A kink at the distal end of the shaft was also noted.The stent was measured to be within specification.No other issues with the stent and delivery system were noted.The damage noted to the delivery system was consistent with excessive force being applied during use.The unraveling of the stent may have been due to manipulation, excessive handling or resistance while the stent was deployed or removed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to procedural factors such as handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause is adverse event related to the 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.
Event or Problem Description
It was reported to boston scientific corporation on april 15, 2019 that an ultraflex tracheobronchial covered distal release stent was used during an airway stent implantation procedure performed on (b)(6) 2019.According to the complainant, during stent deployment, the delivery system bent and the stent was deployed into the wrong lung.The physician had to extubate to remove the stent from the patient.Reportedly, the case was completed with no patient complications.Despite numerous attempts, boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8595493
• Report Number: 3005099803-2019-02340
• Device Sequence Number: 11279126
• Product Code: JCT
• UDI-Device Identifier: 08714729842385
• UDI-Public: 08714729842385
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/04/2019

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: 04/18/2020
• Device Model Number: M00576580
• Device Catalogue Number: 7658
• Device Lot Number: 0022011992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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