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

Model Number	M00534360
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent with naviflex delivery system was noticed to have moisture inside the sterile pouch when the package was taken out from the transportation box on (b)(6) 2026.Reportedly, the product did not seem to have any mechanical damage.There was no patient involvement.
Additional Manufacturer Narrative
Block h6: imdrf device code a1801 captures the reportable event of device not sterile.

• Brand Name: ADVANIX? BILIARY
• 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: 24916465
• Report Number: 3005099803-2026-01426
• Device Sequence Number: 9196153
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: (01)08714729787457(17)271202(10)38354570
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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 Model Number: M00534360
• Device Catalogue Number: M00534360
• Device Lot Number: 0038354570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2025
• 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
• Patient Sex: Unknown