MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Ultraflex? Esophageal NG; prosthesis, esophageal

Model Number	M00513730
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code (b)(6)captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal release covered stent was to be implanted in the esophagus to treat an esophageal stenosis during a stent placement procedure performed on (b)(6), 2026.During the procedure, it was noted that the stent was kinked, and the wire could not be pulled.The device was removed, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition was reported to be stable.

• 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 ; +1(914)571-6918
• MDR Report Key: 50202713
• Report Number: 3005099803-2026-03253
• Device Sequence Number: 5521716
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)270327(10)36166408
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0036166408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 03/27/2025
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 138 LB