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

Model Number	M00536520
Medical Device Problem Codes	Difficult to Advance (2920); 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	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This report pertains to one of two advanix pancretaic stents used during the same procedure.Refer to manufacturer report# 3005099803-2025-02867 and 3005099803-2025-02866 for the associated device information.It was reported to boston scientific corporation that two advanix pancreatic stents were to be implanted in the pancreatic duct during an endoscopic pancreatic duct stent placement procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the first advanix pancreatic stent (subject of manufacturer report # 3005099803-2025-02867) was attempted to be placed.However, the stent was unable to cross the stenosis.It was noted that there was a bump between the guide catheter and the stent device.A second advanix pancreatic stent (subject of this report) was attempted to be placed, but the same thing happened.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked.
Event or Problem Description
This report pertains to one of two advanix pancretaic stents used during the same procedure.Refer to manufacturer report# 3005099803-2025-02867 and 3005099803-2025-02866 for the associated device information.It was reported to boston scientific corporation that two advanix pancreatic stents were to be implanted in the pancreatic duct during an endoscopic pancreatic duct stent placement procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the first advanix pancreatic stent (subject of manufacturer report # 3005099803-2025-02867) was attempted to be placed.However, the stent was unable to cross the stenosis.It was noted that there was a bump between the guide catheter and the stent device.A second advanix pancreatic stent (subject of this report) was attempted to be placed, but the same thing happened.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked.Block h11: an advanix pancreatic stent received for analysis.Visual inspection found the stent kinked and damaged, and the stent was stuck in the naviflex delivery system.No other issues were noted with the stent.Product analysis confirmed the reported event of stent kinked as the stent was returned kinked and damaged.The reported event of stent difficult to advance cannot be confirmed as this event happened during the procedure.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely caused by manipulation of the device during its placement into the scope, or the technique used by the physician may have affected the positioning of the stent within the scope, or when taking it out of the package.Therefore, the most probable cause of the reported event is adverse event related to procedure a labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The event occurred on may 30, 2025.However, the device expired on november 09, 2024.The ifu states, "rotate inventory so that products are used prior to the expiration date on package label.".

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22321063
• Report Number: 3005099803-2025-02866
• Device Sequence Number: 8988435
• Product Code: FGE
• UDI-Device Identifier: 08714729857464
• UDI-Public: (01)08714729857464(17)241109(10)31602217
• 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): 08/13/2025

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: 11/09/2024
• Device Model Number: M00536520
• Device Catalogue Number: M00536520
• Device Lot Number: 0031602217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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