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

Model Number	M00532190
Medical Device Problem Codes	Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a advanix-naviflex biliary stent was to be implanted to treat a biliary stricture in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, could not found the x-ray marker.Another advanix-naviflex biliary sten was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020602 captures the reportable event of ro marker band missing.
Additional Manufacturer Narrative
Block b5 and block h6 has been updated.Block h6: imdrf device code a24 captures that the event was incorrectly reported.
Event or Problem Description
It was reported to boston scientific corporation that a advanix-naviflex biliary stent was to be implanted to treat a biliary stricture in the biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, could not found the x-ray marker.Another advanix-naviflex biliary sten was used to complete the procedure.There were no patient complications reported as a result of this event.Additional information received on february 20, 2026.It was reported that the guide catheter's radiopaque marker cannot be confirmed.

• Brand Name: ADVANIX? 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23778812
• Report Number: 3005099803-2025-06675
• Device Sequence Number: 10057781
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: (01)08714729786986(17)270811(10)37177659
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101786
• 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
• Report Date (Section B): 03/03/2026

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: M00532190
• Device Catalogue Number: M00532190
• Device Lot Number: 0037177659
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 08/11/2025
• 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