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

Model Number	M00536580
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted during a leading barb pancreatic duct stent straight leading barb procedure performed on unknown date of procedure.It was reported that dirt on exterior (a sticky residue is present).There were no patient involvement.
Additional Manufacturer Narrative
Block h6: imdrf device code a1801 captures the reportable event of device contamination during use.
Event or Problem Description
It was reported to boston scientific corporation that a advanix pancreatic stent was to be implanted during a leading barb pancreatic duct stent straight leading barb procedure performed on unknown date of procedure it was reported that dirt on exterior (a sticky residue is present) there were no patient involvement.
Additional Manufacturer Narrative
Block h6: imdrf device code a1801 captures the reportable event of device contamination during use.Block h11: an advanix pancreatic stent was not returned for analysis.A media inspection of the photos provided by the complainant noted evidence of residue observed in the package.However, it was not possible to determine the exact position of the residue (whether outside or inside the package).No other damages were noted to the stent and delivery system.Media analysis cannot confirm the reported event of device contamination during use.The customer provided some pictures where it can be showed an unidentified residue in the package whose exact location in the package (outside or inside); however, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.Taking all available information into consideration, the most probable cause of the reported event is cause not established.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23687010
• Report Number: 3005099803-2025-06495
• Device Sequence Number: 12226053
• Product Code: FGE
• UDI-Device Identifier: 08714729857525
• UDI-Public: (01)08714729857525(17)260724(10)35683913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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: 07/24/2026
• Device Model Number: M00536580
• Device Catalogue Number: M00536580
• Device Lot Number: 0035683913
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown