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

Model Number	M00537320
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of stent kinked.Block h11: an advanix pancreatic stent was returned for analysis; the delivery system was not.Visual examination of the returned stent found that it was kinked in the pigtail loop.No other problems were noted to the stent.Product analysis could did not confirmed the reported event of device guidewire stuck as the delivery system was not returned for analysis.The investigation concluded that the additional observed damage of stent kinked and the reported event were most likely a result of the physician technique used during the procedure.However, since the delivery system didn't return for analysis, it's not possible to determine if the stent kink affected the use of the guidewire or if the delivery system had any damage that could have cause the reported allegation.Therefore, cause not established is selected as the most probable root cause.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted to treat pancreatitis during a pancreatic duct stent placement procedure performed on (b)(6) 2025.During the procedure, the guidewire could not be inserted into the stent.Another advanix pancreatic was used to complete the procedure.There were no patient complications 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.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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22206249
• Report Number: 3005099803-2025-02726
• Device Sequence Number: 12453668
• Product Code: FGE
• UDI-Device Identifier: 08714729856917
• UDI-Public: (01)08714729856917(17)250926(10)33712181
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 09/26/2025
• Device Model Number: M00537320
• Device Catalogue Number: M00537320
• Device Lot Number: 0033712181
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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