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

Model Number	M00534230
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 is being used to capture the reportable event of stent catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex stent was implanted to treat a stricture in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the physician noticed that the stricture was tight.When he introduced the stent after cannulating, he had to pull the stent out after it was unable to pass it through.Dilation of the duct was conducted, and another stent placement attempt was made.The stent was then able to be deployed but the guide catheter broke in the process.The catheter was removed, and the stent remains implanted.The procedure was completed successfully.There was no patient complication 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." the user did not follow the ifu; therefore, this complaint has been assigned ar code 5191: 2457 to capture user error.

• 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 ; EI 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21463871
• Report Number: 3005099803-2025-00397
• Device Sequence Number: 8749742
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: 08714729787327
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K203162
• 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): 02/25/2025

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: M00534230
• Device Catalogue Number: M00534230
• Device Lot Number: 0035321940
• 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: 01/31/2025
• Initial Report FDA Received Date: 02/25/2025
• Date Device Manufactured: 10/30/2024
• 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