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

Model Number	M00534290
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted to treat a stone in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2025.The patient's anatomy was tortuous.During the procedure, they carefully pushed the stent into the bile duct, aiming to release it.After removing the guide wire, they noticed the steel stylet was surprisingly easy to pull back.However, the black catheter, which held the stent, did not retract along with it, preventing the stent from being released.It appeared that the steel stylet had disconnected from the black catheter.Another advanix biliary stent with naviflex rx delivery system was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block g4: additional premarket / 510(k) # k203162.Block h6: imdrf device code a0401 captures the reportable event of pull wire break.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22433133
• Report Number: 3005099803-2025-03157
• Device Sequence Number: 4632099
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389(17)260906(10)34951820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101314
• 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): 07/08/2025

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: 09/06/2026
• Device Model Number: M00534290
• Device Catalogue Number: M00534290
• Device Lot Number: 0034951820
• 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: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 09/06/2024
• 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 Sex: Unknown