MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was to be implanted to treat a stricture in the colon during a colonoscopy with colonic stent placement procedure performed on (b)(6) 2025.During the procedure, the delivery system broke in half.The procedure was cancelled.There no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral stent was to be implanted to treat a stricture in the colon during a colonoscopy with colonic stent placement procedure performed on (b)(6) 2025.During the procedure, the delivery system broke in half.The procedure was cancelled.There are no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: a wallflex enteral stent did not return for analysis.However, a media inspection of the photo provided by the complainant noted that there is evidence of stainless steel detachment.No other damages were noted to the stent or the delivery system based on the available documentation.Product analysis confirmed the reported event of handle break.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely related to circumstances that cannot be fully assessed due to the absence of the returned device and the limited evidence regarding device performance during the procedure.Due the lack of the device for evaluation and the absence of objective procedural documentation, there is insufficient evidence to determine whether the handle break resulted from physician manipulation during the procedure or a potential device malfunction.Therefore, a review and analysis of the all the available information indicated that the most probable cause is unable to exclude device problem.

• Brand Name: WALLFLEX? COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 23369279
• Report Number: 3005099803-2025-05546
• Device Sequence Number: 10122574
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: (01)08714729456513(17)260619(10)34271483
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K201159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 06/19/2026
• Device Model Number: M00565040
• Device Catalogue Number: M00565040
• Device Lot Number: 0034271483
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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