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

Model Number	M00565060
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf impact code f2301 captures the reportable event of the detached part was then pushed out into the colon and was retrieved using rat tooth forceps.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted to treat a malignant colonic obstruction during a colonic stent placement procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the wallflex colonic stent was successfully deployed.However, when the nurse re-sheathed the delivery system, the outer tube got stuck in the working channel of the scope and the clear outer sheath broke off.The detached part was then pushed out into the colon and was retrieved using rat tooth forceps, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 was updated based on the additional information received on october 6, 2025.Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf impact code f2301 captures the reportable event of the detached part was then pushed out into the colon and was retrieved using rat tooth forceps.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted to treat a malignant colonic obstruction during a colonic stent placement procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous.During the procedure, the wallflex colonic stent was successfully deployed.However, when the nurse re-sheathed the delivery system, the outer tube got stuck in the working channel of the scope and the clear outer sheath broke off.The detached part was then pushed out into the colon and was retrieved using rat tooth forceps, and the procedure was completed.There were no patient complications reported as a result of this event.***additional information received on october 6, 2025*** it was reported that the stent was implanted in the sigmoid colon.

• 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: 22546937
• Report Number: 3005099803-2025-03408
• Device Sequence Number: 7014084
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: (01)08714729456537(17)251121(10)32906411
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K201159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2025
• Device Model Number: M00565060
• Device Catalogue Number: M00565060
• Device Lot Number: 0032906411
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 11/22/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown