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

Model Number M00564800

Device Problem Activation Failure (3270)

Patient Problems Dyspnea (1816); Pneumothorax (2012)

Event Date 09/29/2020

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 (b)(6) 2020 that an ultraflex tracheobronchial covered distal release stent was implanted in the bronchus to treat a tracheostenosis during a tracheal stent implantation procedure performed on (b)(6) 2020.According to the complainant, after the stent deployed, the physician checked the stent using the scope and noted the stent failed to fully expand.The physician attempted to expand the stent prior to stent removal.Reportedly, after stent implantation, the patient sat up and experienced difficulty breathing leading to pneumothorax.The stent was then removed and another ultraflex tracheobronchial stent was used to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be stable and reportedly, after the second stent was deployed there were no longer any patient complications.The endoscopic stent removal and deployment of the second stent was the only intervention reported to address the difficulty breathing and pneumothorax.

• 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: 10713204
• MDR Text Key: 212465916
• Report Number: 3005099803-2020-04633
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

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: 10/09/2021
• Device Model Number: M00564800
• Device Catalogue Number: 6480
• Device Lot Number: 0024576460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 63