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

Model Number	M00513750
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: investigation results: boston scientific corporation could not confirm the reported events of stent partially deployed, shaft kinked and device difficult to advance guidewire.The device was not returned; therefore, product analysis could not be performed.Based on the information available, there was no evidence to determine whether the reported events were due to physician device manipulation during the procedure or related to a device malfunction.Without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event device technical analysis: the device was not returned; therefore, product analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of stent partially deployed was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng distal covered stent was to be implanted to treat an approximately 10 cm esophageal stricture in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2026.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was advanced over a guidewire; however, resistance was encountered while advancing the delivery system.Despite prior dilation of the stricture, the catheter became bent, preventing successful stent deployment.The stent was removed partially deployed on the delivery system, and the procedure was completed using a different device.There were no patient complications 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: 25607922
• Report Number: 3005099803-2026-02568
• Device Sequence Number: 5534026
• Product Code: ESW
• UDI-Device Identifier: 08714729649113
• UDI-Public: (01)08714729649113(17)270610(10)36718964
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 07/09/2026

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: M00513750
• Device Catalogue Number: M00513750
• Device Lot Number: 0036718964
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 07/09/2026
• Date Device Manufactured: 06/10/2025
• 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 Sex: Unknown