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

Model Number	M00565120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of inner shaft/sheath detachment of device or component.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of inner shaft/sheath detachment of device or component.The device has not been returned for product evaluation as the device was disposed; therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a device malfunction.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the complaint device was not returned for evaluation as the device was disposed; therefore, a technical analysis could not be performed.Risk review: a risk review of the wallflex enteral stents was completed and confirmed that the events of inner shaft/sheath detachment of device or device component were 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 unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was attempted to be implanted during a colonic stent insertion procedure performed on (b)(6) 2026.During procedure, the stent catheter broke.The procedure was completed using an alternate device.There was no patient complications reported as a result of the procedure there was no patient complications reported as a result of this event.

• 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: 24641362
• Report Number: 3005099803-2026-01020
• Device Sequence Number: 9876811
• Product Code: MQR
• UDI-Device Identifier: 08714729456599
• UDI-Public: (01)08714729456599(17)270515(10)36523423
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K234046
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: M00565120
• Device Catalogue Number: M00565120
• Device Lot Number: 0036523423
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 05/15/2025
• 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