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

Model Number	M00565120
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to the intestinal tract to treat an intestinal obstruction during a placement of intestinal metal stenting procedure performed on (b)(6) 2025.Prior to procedure, it was found that the seal package was damaged during clinical inspection.The procedure was completed using another of the same device.There was no patient complications reported as a result of the event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: a wallflex colonic stent was not returned for evaluation; therefore, a product analysis could not perform.However, supporting documentation included photographs where it can be observed the packaging damaged.Media analysis confirmed the reported event of packaging seal compromised.However, without proper evaluation of the device there is not enough evidence to determine if the reported event was due to external factors such as transport and storage.These failures could be caused due to environmental factors during the transport or storage of the device, also an incorrect storage of the device, without the proper conditions could have induced the reported defect.Taking all available information into consideration, the most probable cause is cause traced to transport/storage.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted to the intestinal tract to treat an intestinal obstruction during a placement of intestinal metal stenting procedure performed on (b)(6) 2025.Prior to procedure, it was found that the seal package was damaged during clinical inspection.The procedure was completed using another of the same device.There was no patient complications reported as a result of the 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: 23751767
• Report Number: 3005099803-2025-06641
• Device Sequence Number: 5892721
• Product Code: MQR
• UDI-Device Identifier: 08714729456599
• UDI-Public: (01)08714729456599(17)260915(10)34852555
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201159
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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: 09/15/2026
• Device Model Number: M00565120
• Device Catalogue Number: M00565120
• Device Lot Number: 0034852555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 12/14/2025; 05/28/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/09/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2024
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG