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

Model Number	M00534690
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
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 colon cancer during a endoscopic retrograde cholangiopancreatography (ercp) + endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.Another advanix-naviflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the device analysis results; guide catheter was detached/separated.
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable investigation finding of catheter guide break.H11: an advanix-naviflex biliary stent was returned for analysis.A visual examination of the returned device and microscopic examination was performed, revealed that the push catheter was kinked, the push catheter suture hole was torn, and the guide catheter was detached.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy.Taking all available information into consideration.The investigation concluded that the reported event and observed damages were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician caused the push catheter kinked, the push catheter suture hole was torn, and the guide catheter was detached, making stent deployment impossible.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• 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: 23823480
• Report Number: 3005099803-2025-06737
• Device Sequence Number: 18632751
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: (01)08714729787242(17)270130(10)35844611
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/16/2025

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 Model Number: M00534690
• Device Catalogue Number: M00534690
• Device Lot Number: 0035844611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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