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

Model Number	M00537290
Medical Device Problem Codes	Entrapment of Device (1212); 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	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that two advanix pancreatic stents were to be implanted to treat an unknown indication in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp).During the procedure, both stents were unable to be advanced over the guidewire.Both stents got stuck and bent slightly at the tips.A third advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.
Additional Manufacturer Narrative
B3: approximated based on the date the manufacturer became aware of the event.H6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.H11: an advanix pancreatic stent was received for analysis.The delivery system was not returned.Visual examination revealed that the stent was kinked and torn.No other damage was noted on the stent.Product analysis confirmed the reported event of stent kinked.The investigation concluded that this damage was most likely caused by the manipulation of the device when the stent was tried to be deployed from the delivery system.The reported event of device guidewire stuck could not be confirmed because the delivery system was not returned.Taking all available information into consideration, the overall root cause of the reported events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that two advanix pancreatic stents were to be implanted to treat an unknown indication in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp).During the procedure, both stents were unable to be advanced over the guidewire.Both stents got stuck and bent slightly at the tips.A third advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 21687015
• Report Number: 3005099803-2025-01124
• Device Sequence Number: 8820166
• Product Code: FGE
• UDI-Device Identifier: 08714729856887
• UDI-Public: (01)08714729856887(17)260123(10)34500045
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 01/23/2026
• Device Model Number: M00537290
• Device Catalogue Number: M00537290
• Device Lot Number: 0034500045
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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