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

Model Number	M00537390
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: the exact onset of event was not reported.The reported event date of june 1, 2025, was chosen as the best estimate based on the bsc aware date.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block e1 (initial reporter city): the initial reporter city is saitama city, saitama prefecture.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2202 captures the reportable event of endoscopic procedure performed.Imdrf impact code f2301 captures the reportable event of additional device used to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx pancreatic stent was implanted in the pancreatic duct to prevent pancreatitis due to spontaneous drop during an endoscopic pancreatic drainage procedure performed on (b)(6) 2024.During a routine follow up check-up, a computed tomography (ct) scan was performed and revealed that the stent remained within the intestinal tract and appeared to have penetrated it.The stent was left in place, and a gastroscopy was subsequently performed on (b)(6) 2025.The procedure confirmed that the stump of the pancreatic duct stent had entered the diverticulum and was successfully removed without any signs of perforation.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX? PANCREATIC STENT KIT
• 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: 22572173
• Report Number: 3005099803-2025-03409
• Device Sequence Number: 21278154
• Product Code: FGE
• UDI-Device Identifier: 08714729856382
• UDI-Public: (01)08714729856382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 07/22/2025

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 Model Number: M00537390
• Device Catalogue Number: M00537390
• 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: 06/27/2025
• Initial Report FDA Received Date: 07/22/2025
• 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