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

Model Number M00564910

Device Problem Activation Failure (3270)

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

Event Date 02/20/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2023 that an ultraflex tracheobronchial covered distal stent was to be implanted to treat a lesion in the air duct during a trans-electron bronchoscopic stent placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial stent was placed down to the lesion and the wire was pulled; however, the stent was unable to extend and open the airway stenosis and ensure positioning of the stent.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.

Manufacturer Narrative

Imdrf device code a150101 captures the reportable event of stent failure to expand.

• 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: 16498416
• MDR Text Key: 311047608
• Report Number: 3005099803-2023-01161
• 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: 03/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Model Number: M00564910
• Device Catalogue Number: 6491
• Device Lot Number: 0027178644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 52 KG