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

Model Number	M00534620
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was attempted to be implanted in the common bile duct to treat a stricture during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the stent and sheath got separated.The procedure was completed with another of the same device.There were no patient complications 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 detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.Block h11: an advanix biliary stent with naviflex rx delivery system was returned for analysis.Visual examination of the returned device revealed the guide catheter was detached.Also, the stent suture hole was observed torn, and the suture was attached to the push catheter.Under microscopic inspection, the hypotube was observed broken.No other damages were noted to the stent and delivery system.Product analysis did not confirm the reported event of suture detachment of device or device component; the device was returned with the suture attached to the push catheter.The investigation concluded that the microscopic evaluation indicated the detachment of the guide catheter was consistent with a random failure at the junction between the pull wire and the guide catheter (hypotube).Additionally, it is possible that the force applied during attempts to deploy the stent contributed to tearing at the stent suture hole.Therefore, taking all available information into consideration, the overall root cause of the event is cause traced to component failure.

• 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: 24471423
• Report Number: 3005099803-2026-00768
• Device Sequence Number: 9615864
• Product Code: FGE
• UDI-Device Identifier: 08714729787174
• UDI-Public: (01)08714729787174(17)260719(10)35007715
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 Expiration Date: 07/19/2026
• Device Model Number: M00534620
• Device Catalogue Number: M00534620
• Device Lot Number: 0035007715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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