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 an advanix pancreatic stent was implanted to treat an unknown indication in the pancreatic duct during an rndoscopic retrograde cholangiopancreatography (ercp).During the procedure, they were unable to advance the stent over the wire.Both stents stuck and bent slightly at the tips.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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
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.Block h11: an advanix pancreatic stent was received for analysis.A visual examination revealed that the stent was kinked and torn.No other damage was noted on the stent.The product analysis confirmed the reported event of stent kinked.The observed damage was most likely caused by manipulation of the device when the stent was tried to be deployed from the delivery system.Therefore, a review and analysis of all available information indicated that the most probable cause is an adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted to treat an unknown indication in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp).Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.During the procedure, they were unable to advance the stent over the wire.Both stents stuck and bent slightly at the tips.Another 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: 21664892
• Report Number: 3005099803-2025-01125
• Device Sequence Number: 20739286
• 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): 04/28/2025

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: 03/21/2025
• Supplement Report FDA Received Date: 04/28/2025
• 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