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

Model Number	M00534290
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: the advanix biliary stent and delivery system was not returned for evaluation because the stent remained implanted.Therefore, product analysis could not be performed.However, the documentation provided includes photos where it can be observed the pull wire bent and dislodged from the catheter.Also, it can be observed the label information of the device.However, the guide catheter was not visible in the images, so it is not possible to determine whether it had detached from the device.Media analysis could not confirm the reported event of a guide catheter break, as the documentation indicated that the guide catheter was not visible.However, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.There is not enough evidence to determine if the reported event was related to the physician's technique during the procedure, due to the anatomical conditions or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted to the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient did not have a torturous anatomy.During a stent deployment procedure, the stent was initially placed in the correct anatomical location, and the guidewire was successfully removed.However, upon deploying the stent, the inner wire of the catheter unexpectedly detached from the delivery system.This resulted in the inner wire becoming stuck within the delivery system while still inside the patient.To resolve the issue, the physician manually pulled the inner wire, which inadvertently caused the stent to shear from the distal flange to the end.Despite this mechanical failure, the stent remained in its intended position, and no displacement occurred.When the delivery system was removed from the patient, the broken guide catheter remained within the push catheter enabling for the delivery system to be removed in one piece.The procedure was completed using the original device.There were no patient complications reported as a result of the 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: 23648834
• Report Number: 3005099803-2025-06497
• Device Sequence Number: 9896658
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389(17)270325(10)36190029
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K251291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: M00534290
• Device Catalogue Number: M00534290
• Device Lot Number: 0036190029
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 03/25/2025
• 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