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

Model Number	M00514250
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Imdrf impact code f2301 captures the additional device used to remove the foreign material.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stents was implanted to treat an esophageal stricture during a procedure performed on (b)(6) 2025.During the procedure, when the stent was deployed, a small metal ring-shaped object was noted inside the stent.The metal ring was removed from the patient.The stent remains implanted, and the procedure was completed.There were no patient complications reported due to this event.Note: a photo of the complaint device was provided by the complainant, showing that the stent was deployed inside the patient with a small metal ring-shaped object inside the stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stents was implanted to treat an esophageal stricture during a procedure performed on (b)(6) 2025.During the procedure, when the stent was deployed, a small metal ring-shaped object was noted inside the stent.The metal ring was removed from the patient.The stent remains implanted, and the procedure was completed.There were no patient complications reported due to this event.Note: a photo of the complaint device was provided by the complainant, showing that the stent was deployed inside the patient with a small metal ring-shaped object inside the stent.
Additional Manufacturer Narrative
Block g1 (manufacturer contact person) has been updated.Block h6: imdrf device code a180104 captures the reportable event of foreign material present in device.Imdrf impact code f2301 captures the additional device used to remove the foreign material.Block h11: the ultraflex esophageal stent was not returned, only a small metal ring-shaped part was returned for analysis.Visual inspection showed a metal ring-shaped object inside the stent.Device analysis confirmed the reported event of device foreign material present in device.There is not enough evidence to determine if the reported event was related to the physician's technique during the procedure, due to the anatomical conditions or related to a device malfunction.Therefore, based on all available information, the most probable cause selected is cause not established.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• Common Device Name: 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22030256
• Report Number: 3005099803-2025-02207
• Device Sequence Number: 12870908
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: (01)08714729716112(17)261111(10)35254041
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: M00514250
• Device Catalogue Number: M00514250
• Device Lot Number: 0035254041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 09/21/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown