MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Advanix? Biliary; Catheter, Biliary, Diagnostic

Model Number	M00534660
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded stent was to be implanted in the left hepatic duct to treat stenosis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2026.During the procedure, resistance was encountered during stent deployment.It was noted that the internal metal guidewire of the delivery system had fractured and was no longer traversing the entire length of the catheter.As a result, the stent could not be deployed.During removal of the device, a portion of the black inner catheter became visible.The exposed portion was grasped with a snare; however, it fractured, and a segment remained attached to the stent.The push catheter was also reported to have fractured.The procedure was subsequently completed using another device of the same model.There were no patient complications reported as a result of this event and the patient condition following the procedure was reported to be good.Note: the advanix biliary stent had expired on (b)(6) 2025 but was used on (b)(6) 2026.
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 the additional device required to retrieve the broken device fragment.

• 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 ; +1(914)571-6918
• MDR Report Key: 50085280
• Report Number: 3005099803-2026-03095
• Device Sequence Number: 18642480
• Product Code: FGE
• UDI-Device Identifier: 08714729787211
• UDI-Public: (01)08714729787211(17)250522(10)34260505
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Expiration Date: 05/22/2025
• Device Model Number: M00534660
• Device Catalogue Number: M00534660
• Device Lot Number: 0034260505
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2024
• 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: Unknown