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

Model Number	M00537120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a stent break.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was implanted to treat a pancreatic stent in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent was bent in half during deployment.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b5 has been corrected.Blocks b1, b2, b5, e1 (initial reporter title and initial reporter last name), h1, h6 (impact codes) and h11 have been updated with the additional information received on april 07, 2025.Block h6: imdrf device code a0401 captures the reportable event of a stent break.Imdrf impact code f2301 captures the reportable event of an additional intervention performed to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted in the pancreatic duct to prevent post ercp pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent was bent in half during deployment.Another advanix pancreatic stent was used to complete the procedure.There were no patient complications as a result of this event.***additional information received on april 07, 2025*** it was reported that the stent was removed using forceps.

• 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: 21806796
• Report Number: 3005099803-2025-01549
• Device Sequence Number: 7329343
• Product Code: FGE
• UDI-Device Identifier: 08714729856597
• UDI-Public: (01)08714729856597(17)250528(10)32929544
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2025
• Device Model Number: M00537120
• Device Catalogue Number: M00537120
• Device Lot Number: 0032929544
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown