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

Model Number	M00534330
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Use of Device Problem (1670); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was attempted to be implanted to treat choledocholithiasis during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During procedure, the patient underwent a successful endoscopic retrograde cholangiopancreatography (ercp) with complete stone extraction and satisfactory ductal clearance.At the conclusion of the procedure, an attempt was made to place the advanix biliary stent; however, significant resistance was encountered when the stent reached the elevator of the scope, which caused the stent to get stuck and could neither be deployed nor withdrawn.The physician attempted several troubleshooting steps, including advancing and retracting the device and removing the guidewire from the scope.Despite these efforts, the stent remained stuck.The physician then removed the entire scope from the patient with the stent still trapped inside.An alternate ercp scope was introduced, and a new plastic stent was successfully deployed.The patient experienced no complications and fully recovered.Note: a photo of the complaint device was provided, and it showed that the stent was broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.

• 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: 25248290
• Report Number: 3005099803-2026-02018
• Device Sequence Number: 15843605
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426(17)280114(10)38418602
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• 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: M00534330
• Device Catalogue Number: M00534330
• Device Lot Number: 0038418602
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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