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

Model Number M00564880

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).An ultraflex tracheobronchial covered stent and delivery system were received for analysis.The stent and delivery system were received for analysis; a visual examination of the returned device found the stent was partially deployed and the loops of the stent were bent.A piece of stent wire fragment (not derived from the stent) was returned engaged with the crocheted suture.Functional evaluation was performed; however, the stent could not be fully deploy due to the condition of the device received.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was likely due to a stent wire fragment (not derived from the stent) which was returned attached to the crocheted deployment suture which prevented further pulling of the deployment suture.The investigation concluded that the stent wire fragment attached to the crocheted deployment suture is traced to manufacturing related problem.Additionally, there is no sufficient information of what could be the cause of the stent loops bent.However, a review and analysis of all available information indicated the most probable cause of the deployment problem is manufacturing deficiency.An investigation is in place to address the problem of a piece of stent wire fragment (not derived from the stent) was returned engaged with the crocheted suture.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the trachea during a stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was partially deployed.The procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent loops were bent.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10817829
• MDR Text Key: 225872094
• Report Number: 3005099803-2020-05099
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: M00564880
• Device Catalogue Number: 6488
• Device Lot Number: 0025595913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1