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

Model Number M00564520

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  Injury  

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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation on november 22, 2019 that an ultraflex tracheobronchial uncovered distal release stent was to be used to treat for stenosis during a bronchoscopy with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, it was noticed that the stent failed to fully expand.The stent was removed from the patient and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complication reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex tracheobronchial uncovered distal release stent was to be used to treat for stenosis during a bronchoscopy with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, it was noticed that the stent failed to fully expand.The stent was removed from the patient and another ultraflex tracheobronchial stent was implanted to complete the procedure.There were no patient complication reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.***additional information received on (b)(6) 2020*** according to the complainant, the initial report of failure to expand after deployment was the wrong description, the stent was partially deployed and still connected to the delivery system.The stent was unable to unfold.

Manufacturer Narrative

Blocks b5 and h6 (device code) have been updated with additional information received on (b)(6), 2020.Block h6: device problem code 3270 captures the reportable event of stent failed to expand.Block h10: an ultraflex tracheobronchial uncovered distal release stent, delivery system and deployment suture were returned for analysis.Visual examination of the returned device found the stent was received partially deployed.Functional evaluation revealed that it was possible to deploy the stent by pulling the finger ring without resistance.The stent was measured to be within specifications.No other issues were noted with the stent and delivery system.The observed failure and the reported event may be related to procedural factors, such as handling of the device, the techniques 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 procedure.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.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9460951
• MDR Text Key: 174659348
• Report Number: 3005099803-2019-05949
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: M00564520
• Device Catalogue Number: 6452
• Device Lot Number: 0024234252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention