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

Model Number	M00537560
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6); reported here as it exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of a stent break.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted in the pancreatic duct during a pancreatic duct stent placement procedure performed on (b)(6) 2025.During the procedure, the lumen of the stent collapsed.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted in the pancreatic duct during a pancreatic duct stent placement procedure performed on (b)(6) 2025.During the procedure, the lumen of the stent was found to have collapsed, with the cylinder of the stent appearing crushed or dented, and external damage also noted.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5, h6 (device codes), and h11 have been corrected.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a0406 captures the reportable event of a stent material deformation.

• Brand Name: ADVANIX? PANCREATIC STENT KIT
• 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: 21914633
• Report Number: 3005099803-2025-01776
• Device Sequence Number: 9390878
• Product Code: FGE
• UDI-Device Identifier: 08714729856337
• UDI-Public: (01)08714729856337(17)260301(10)34811982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 03/01/2026
• Device Model Number: M00537560
• Device Catalogue Number: M00537560
• Device Lot Number: 0034811982
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 06/29/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 08/30/2024
• 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