MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX? BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to the bile duct to treat a stricture measuring approximately 11 mm caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed around (b)(6) 2025.The patient's anatomy was dilated prior to stent placement.Two months post procedure, during a follow up examination, it was found that the stent had migrated into the duodenum.The migrated stent was removed on the same day using forceps.The procedure was then completed using another device of the same type.There were no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block e1 initial reported address: (b)(6).Block h6: imdrf device code a010402 captures the reportable event of stent migration.

• Brand Name: WALLFLEX? BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: christin lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24119423
• Report Number: 3005099803-2026-00247
• Device Sequence Number: 5941728
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: (01)08714729764915(17)270310(10)36025782
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K140630
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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 Model Number: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0036025782
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 03/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown