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

Model Number	M00534700
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the use of rat tooth forceps to retrieve the stent and introducer.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was to be implanted in the biliary duct to treat an obstruction due to chronic pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on july 15, 2025.The patient's anatomy was not dilated and tortuous.During the procedure, resistance was encountered during stent deployment, resulting in the detachment of the black introducer from the pushing component of the delivery system.The inner guide catheter fractured into two pieces.Attempts to troubleshoot by retracting and advancing the introducer via the naviflex handle were unsuccessful.The team proceeded to remove the pushing catheter and successfully retrieved both the stent and introducer using a rat tooth forceps.The procedure was successfully completed using another device of the same model.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.".

• 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: 22719739
• Report Number: 3005099803-2025-03812
• Device Sequence Number: 21133919
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: (01)08714729787259(17)261216(10)35554134
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00534700
• Device Catalogue Number: M00534700
• Device Lot Number: 0035554134
• 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: 07/15/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 12/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American