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

Model Number	M00534240
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	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, the guide catheter broke inside the endoscope.The physician used a grasper to remove the broken guide catheter fragment, and the procedure was able to be completed successfully.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required, as graspers were required to retrieve the broken fragment of the guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, the guide catheter broke inside the endoscope.The physician used a grasper to remove the broken guide catheter fragment, and the procedure was able to be completed successfully.Reportedly, the procedure was extended as a result of the issue.However, there were no patient complications reported.***additional information received on december 11, 2025*** 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.
Additional Manufacturer Narrative
Block b5 (describe event or problem) and h6 (device codes) have been updated with additional information received from (b)(6), (gi associate territory manager iv) on december 11, 2025.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required, as graspers were required to retrieve the broken fragment of the guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, the guide catheter broke inside the endoscope.The physician used a grasper to remove the broken guide catheter fragment, and the procedure was able to be completed successfully.Reportedly, the procedure was extended as a result of the issue.However, there were no patient complications reported.
Additional Manufacturer Narrative
Block b5 and h6 (device codes) have been corrected.Per further review of the information received, the device was deemed to have been used within label.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required, as graspers were required to retrieve the broken fragment of the guide catheter.

• 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: 23318777
• Report Number: 3005099803-2025-05362
• Device Sequence Number: 4877946
• Product Code: FGE
• UDI-Device Identifier: 08714729787334
• UDI-Public: (01)08714729787334(17)270617(10)36839813
• 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,Followup,Followup
• Report Date (Section B): 02/09/2026

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: M00534240
• Device Catalogue Number: M00534240
• Device Lot Number: 0036839813
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 01/16/2026
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/05/2026; 02/09/2026
• Date Device Manufactured: 06/17/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown