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

Model Number	M00534370
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, "when the prosthesis was released, the carrier catheter failed".The device was removed, and the procedure was completed.No patient complications were reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the guide catheter was detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter phone: (b)(6).Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.H11: block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.Block h11: an advanix- naviflex stent and delivery system were returned for analysis.Visual and microscopic examination of the returned device found the guide catheter detached and kinked, the pull wire was kinked.The stent suture hole and push catheter suture hole were torn, and the suture was detached.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy.The guide catheter returned detached was likely due to factors encountered during the procedure.It may be that the tortuosity encountered during the procedure, the force applied and/or the technique used by the physician, limited the performance of the device and contributed to the reported event and observed problems.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu) / product label.

• 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: 22023093
• Report Number: 3005099803-2025-02186
• Device Sequence Number: 9411564
• Product Code: FGE
• UDI-Device Identifier: 08714729787464
• UDI-Public: (01)08714729787464(17)260405(10)34910297
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/14/2025

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: 04/05/2026
• Device Model Number: M00534370
• Device Catalogue Number: M00534370
• Device Lot Number: 0034910297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• 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