MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number M00514250

Device Problems Break (1069); Human-Device Interface Problem (2949); Device Stenosis (4066)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an ultraflex esophageal proximal release covered stent was implanted in the esophagus for the treatment of a 2cm stenosis due to esophageal cancer during a gastroscopy procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2023, it was observed that the stent's distal end had overgrowth.The stent was moved slightly distally using rat tooth grasping forceps.During the procedure, it was also noted that the stent was obstructed by a small amount of food.The physician pushed past some impacted food and found that the stent had broken into two pieces.The patient was referred to a different hospital for stent removal and placement of a new stent.No patient complications were reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a22 captures the reportable event of stent overgrowth.Imdrf device code a0106 captures the reportable event of stent obstruction.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f23 captures the reportable event of additional intervention performed to adjust the position of the stent.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 18501852
• MDR Text Key: 332761911
• Report Number: 3005099803-2023-06950
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K091816
• 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: 01/12/2024

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 Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0031373096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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 Outcome(s): Required Intervention