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

Model Number	M00537390
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation finding of stent kinked.Block h11: an advanix pancreatic stent was received for analysis.Visual and microscopic examination of the returned device found the stent kinked, and the guidewire port from the pusher damaged.Functional inspection was performed, and it was observed that the guidewire gets stuck against the guidewire port.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of device guidewire stuck.The investigation concluded that the additional observed malfunctions of guidewire port damaged and stent kinked may be consistent with the good faith effort response, which indicated that there could be signs of the exit port having been forcibly widened by the nurse where the pusher's guidewire comes out.However, from a product analysis point of view, it is not possible to determine the exact cause of why the guidewire did not pass the guidewire exit port during procedure, as the conditions and manner in which the device was used during the procedure could not be verified.Therefore, the most probable cause of the events is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx pancreatic stent was to be implanted in the pancreatic duct to treat a suspected pancreatic cancer during an endoscopic pancreatic drainage procedure performed on (b)(6) 2025.During the procedure, it was observed that the hole in the accessory pusher was too small, which prevented the guidewire from exiting as intended.There may be traces of the exit being forcibly widened by the nurse where the pusher's guidewire comes out.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the stent was kinked.Please see block h11 for the full investigation details.

• 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: 22312571
• Report Number: 3005099803-2025-02854
• Device Sequence Number: 8924669
• Product Code: FGE
• UDI-Device Identifier: 08714729856382
• UDI-Public: (01)08714729856382(17)251030(10)33974083
• 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): 06/23/2025

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: 10/30/2025
• Device Model Number: M00537390
• Device Catalogue Number: M00537390
• Device Lot Number: 0033974083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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