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

Model Number	M00513740
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1 (initial reporter address): (b)(6); reported here as it exceeded the character limit for the designated field.Block h6: imdrf impact code f1001 captures the reportable event of aborted/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal ng stent was to be implanted to treat a tight 4 cm mid-esophageal stricture during an esophageal stenting procedure performed on (b)(6) 2025.During the procedure, while loading the stent onto the guidewire, the delivery catheter became kinked, preventing successful advancement of the stent.Despite removing and reinserting the device and replacing the guidewire, the physician was unable to deploy the stent due to persistent catheter kinking.The procedure was aborted and rescheduled for a later date.There were 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, H91 Y 868; EI H91 Y868
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 22581247
• Report Number: 3005099803-2025-03520
• Device Sequence Number: 18149905
• Product Code: ESW
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/31/2026

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 Expiration Date: 10/12/2025
• Device Model Number: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0032628951
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2025
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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