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

Model Number M00564560

Device Problems Break (1069); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial uncovered distal stent was to be implanted in the main airway to treat stenosis during a transbronchial tracheal stent implantation procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the stent deployment suture broke, and the stent could not be deployed.The stent was removed from the patient partially deployed on the delivery system, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event and the patient's condition after the procedure was reported to be stable.Note: it was reported that the ultraflex tracheobronchial stent was to be implanted for main airway stenosis with no malignancy.Per the instructions for use (ifu), "the ultraflex tracheobronchial stent system is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms." the stent is not indicated for a main airway stenosis with no malignancy.

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of partial stent deployment.

• 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: 19215828
• MDR Text Key: 341468603
• Report Number: 3005099803-2024-01948
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K012883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: M00564560
• Device Catalogue Number: 6456
• Device Lot Number: 0028966252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG