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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of pull wire break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted to the duodenal papilla to treat lithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The anatomy of the patient was torturous.During procedure, prior to releasing the stent, the wire connecting the stent to the carrying catheter broke during the insertion of the catheter into the duodenal papilla.As a result, it was not possible to place the stent, which prolonged the duration of the procedure for approximately twelve minutes.It was unknown on how the procedure was completed.There was no patient complications reported as a result of the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b5 and h6 (device code) have been corrected.Block h11: at this time the device is currently undergoing technical analysis.The investigation is not yet complete.A supplement report will be submitted once the results are available.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded stent was intended to be implanted in the duodenal papilla to treat biliary lithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.The patient's anatomy was described as tortuous.During insertion of the delivery catheter into the papilla, the suture wire connecting the stent to the carrying catheter detached prematurely.Under normal conditions, this suture detaches only after the guidewire is removed; however, in this case, the detachment occurred before guidewire withdrawal, preventing the stent from being released.The duration of the procedure was prolonged by approximately twelve minutes.However, it remains unknown what device was used to complete the procedure.No patient complications were reported as a result of the event.

• 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: 24574800
• Report Number: 3005099803-2026-00905
• Device Sequence Number: 13380598
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: (01)08714729787433(17)270725(10)37124020
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0037124020
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/18/2026; 04/15/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/03/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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