MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WallFlex? Esophageal; Prosthesis, Esophageal

Model Number	M00516950
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	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted in the esophagus during an esophageal stent placement procedure performed on (b)(6)2026.During the preparation prior to the procedure, the stent was opened and a white string was observed exiting the distal cap directly out of the box.The device was not used, and another wallflex esophageal stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of device - foreign material present in device.Block h11: investigation results: boston scientific corporation confirmed the reported event of device foreign material present in device.The investigation concluded that there is not enough evidence to determine whether the reported event device foreign material present in device was related to a manufacturing issue, packaging condition, handling, storage, transportation, or another contributing factor.Additionally, the evidence from the product record review did not identify a potential product quality problem or new patient harm.Without the ability to examine the device, the most probable cause of the event remains unknown.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.However, a media inspection was performed on a photograph provided by the complainant.The photograph showed evidence of the distal tip of the device with a foreign material protruding from the tip area.Similar complaint review: a similar complaint review was completed.There were no emerging trends identified that warrant further action.Investigation conclusion: based on the available information, there is not enough evidence to confirm the cause of reported event.Without proper evaluation of the complaint device, cause not established is selected as the investigation conclusion code.

• Brand Name: WallFlex? Esophageal
• 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 H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50112134
• Report Number: 3005099803-2026-03131
• Device Sequence Number: 10744337
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: (01)08714729765295(17)270114(10)35622925
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K233939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: M00516950
• Device Catalogue Number: M00516950
• Device Lot Number: 0035622925
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 01/14/2025
• 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