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

Model Number	M00576430
Medical Device Problem Codes	Unraveled Material (1664); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (b)(6) 2019 that an ultraflex tracheobronchial uncovered proximal release stent was to be used during a tracheobronchial stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was partially deployed and the metal stent was noted to be frayed.The stent was removed and the procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Problem code 1664 captures the reportable event of stent metal wire unraveled.Problem code 2906 captures the reportable event of proximal release stent partially deployed.A fully deployed ultraflex tracheobronchial uncovered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found the stent was unraveled and expanded.The green retention sutures were present and no anomalies were noted.The stent was measured to be within specifications.No other issues were noted to the stent.The damage noted to the returned device may have happened due to manipulation, excessive handling or resistance encountered during stent deployment.The investigation concluded that the reported event was likely due to procedural factors such as handling of the device, the techniques used by the user and normal procedural difficulties encountered during the procedure, which may have 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 january 31, 2019 that an ultraflex tracheobronchial uncovered proximal release stent was to be used during a tracheobronchial stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was partially deployed and the metal stent was noted to be frayed.The stent was removed and the procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.

• 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: 8371367
• Report Number: 3005099803-2019-00903
• Device Sequence Number: 1332432
• Product Code: JCT
• UDI-Device Identifier: 08714729837794
• UDI-Public: 08714729837794
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: M00576430
• Device Catalogue Number: 7643
• Device Lot Number: 22734325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1