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

Model Number M00564870

Device Problems Break (1069); Unraveled Material (1664); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a15 captures the reportable event of partially deployed ultraflex tracheobronchial stent.Imdrf device code a040508 captures the reportable event of stent unraveled.

Event Description

It was reported to boston scientific corporation that an ultraflex tracheobronchial covered stent was to be implanted to treat a main tracheal stenosis during a transbronchoscopic with stent placement procedure performed on (b)(6) 2024.The patient's anatomy was dilated prior to stent placement.During the procedure, the stent did not fully deploy.The physician adjusted the position of the stent, but the stent became stretched.The physician used a non-boston scientific biopsy forceps, but the biopsy forceps got entangled with the stent.The stent was removed from the patient together with the delivery system and biopsy forceps.Outside the patient, the physician cut the stent off as it was entangled with the biopsy forceps.The procedure was completed with another ultraflex tracheobronchial stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Note: a photo of the complaint device was provided by the complainant and showed the stent was outside the patient, unraveled and was fully deployed off from the delivery system.

• 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: 18996786
• MDR Text Key: 338986583
• Report Number: 3005099803-2024-01283
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00564870
• Device Catalogue Number: 6487
• Device Lot Number: 0031469589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 55 KG