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

Model Number	M00537260
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); 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	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation finding of pancreatic stent kinked.Block h11: an advanix pancreatic stent was returned for analysis.Visual examination of the returned device identified that the stent was kinked.No other damages were noted.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded that the reported event and additional observed damage were most likely caused because the instructions for use (ifu) were not followed.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." therefore, the most probable root cause is failure to follow instructions.A labeling review was performed, and from the information available, the device was used in a manner inconsistent with the ifu/product label.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted to treat a malignant pancreatic duct stricture in the pancreatic duct head region during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent failed to deploy.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the instructions for use (ifu).Note: this event has been deemed a reportable event based on the investigation finding of stent kinked.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: 23638985
• Report Number: 3005099803-2025-06209
• Device Sequence Number: 9258603
• Product Code: FGE
• UDI-Device Identifier: 08714729856856
• UDI-Public: (01)08714729856856(17)260808(10)35798014
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 11/24/2025

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: 08/08/2026
• Device Model Number: M00537260
• Device Catalogue Number: M00537260
• Device Lot Number: 0035798014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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