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

Model Number	M00536890
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted during an endoscopic retrograde pancreatic drainage (erpd) procedure performed on (b)(6) 2025.During the procedure, the distal part was bent.The procedure was completed using this device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the pusher, the stent cannot be fully deployed." the user did not follow the instructions for use.
Additional Manufacturer Narrative
Blocks b5, e1, and g2 (report source) have been corrected.Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted to treat an endoscopic retrograde pancreatic drainage during an endoscopic retrograde pancreatic drainage (erpd) procedure performed on (b)(6) 2025.During the procedure, the distal part was bent.Original device was used to complete the procedure.There were no patient complications as a result of this event.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the pusher, the stent cannot be fully deployed.".

• 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: 22513211
• Report Number: 3005099803-2025-03306
• Device Sequence Number: 9247237
• Product Code: FGE
• UDI-Device Identifier: 08714729856481
• UDI-Public: (01)08714729856481(17)260604(10)35408907
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 06/04/2026
• Device Model Number: M00536890
• Device Catalogue Number: M00536890
• Device Lot Number: 0035408907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/06/2025
• Date Device Manufactured: 12/03/2024
• 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