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

Model Number	M00513740
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was attempted to be implanted to the esophagus to treat a severe stricture during an esophageal stent placement procedure performed on (b)(6) 2026.During the procedure, the stent was dislocated and could not cross the stenosis lesion.The procedure was completed using a different device.There was no patient complications reported as a result of this event.

• 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: 24811403
• Report Number: 3005099803-2026-01259
• Device Sequence Number: 5952023
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: (01)08714729716167(17)270213(10)35847590
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026

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: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0035847590
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/13/2026; 05/14/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/12/2026; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG