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

Model Number	M00537280
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation finding of stent material deformation.Block h11: an advanix pancreatic stent and its delivery system was returned for analysis.Visual examination of the returned device revealed that the stent was kinked and damaged.Product analysis confirmed the reported event of stent failure to deploy.The investigation determined that the reported event and the observed stent damage were most likely attributable to procedural factors, including device handling and the physician technique, such as the amount of force applied during use.These factors likely contributed to the stent becoming kinked and damaged, which may have made deployment difficult or impossible.Therefore, a review and analysis of all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the main pancreatic duct to treat a pancreatic cancer during a stent placement procedure performed on (b)(6) 2025.During the procedure, that device release was attempted at the intended site, but the inner tube could not be withdrawn.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent was kinked and damaged.Please see block h11 for full investigation details.

• Brand Name: ADVANIX? PANCREATIC STENT
• 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: 24130754
• Report Number: 3005099803-2026-00263
• Device Sequence Number: 13360614
• Product Code: FGE
• UDI-Device Identifier: 08714729856870
• UDI-Public: (01)08714729856870(17)270108(10)36929541
• 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
• Report Date (Section B): 01/21/2026

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: M00537280
• Device Catalogue Number: M00537280
• Device Lot Number: 0036929541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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
• Patient Sex: Unknown