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

Model Number	M00534260
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used in the bile duct for a choledocalithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the nurse tried to shorten the introducer but it was not working and it was broken.The procedure was completed with a different device.There were no patient complications as a result of this event.Note: it was reported that the guidewire was in the patient.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Blocks b5 and h6 has been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used in the bile duct for a choledocalithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the nurse tried to shorten the introducer but it was not working and it was broken.The procedure was completed with a different device.There were no patient complications as a result of this event.

• 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: 23899170
• Report Number: 3005099803-2025-06903
• Device Sequence Number: 20106872
• Product Code: FGE
• UDI-Device Identifier: 08714729787358
• UDI-Public: (01)08714729787358(17)270821(10)37657316
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/21/2026

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: M00534260
• Device Catalogue Number: M00534260
• Device Lot Number: 0037657316
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 08/21/2025
• 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