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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that an advantix biliary stent with naviflex rx delivery system was to be implanted to treat a biliary obstruction in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the proximal flank of the stent was noticed to be fractured.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an advantix biliary stent with naviflex rx delivery system was to be implanted to treat an obstruction in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the proximal flank of the stent was noticed to be fractured.Another of the same device was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on july 17, 2025.It was confirmed that the stent was broken and there were no other problems noted with the device.
Additional Manufacturer Narrative
Blocks b5 and e1 have been updated based on the additional information received on july 17, 2025.Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: an advanix biliary stent with naviflex rx delivery system were received for analysis.Visual inspection revealed that the push catheter was bent near the handle.Additionally, the suture hole on the push catheter was torn, and one of the stent barbs was found to be missing, it was detached.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent break.It was reported that one of the stent barbs was found fractured upon unpacking the device.However, based on procedural steps outlined in the attach stent document, such damage should have been detected during manufacturing.Steps involving suture threading and guide catheter advancement offer opportunities to identify structural defects prior to final assembly.The investigation concluded that the reported event and observed damages were likely due to factors encountered during the procedure.It is possible that the handling of the device during preparation, and the technique used by the physician limited the performance of the device and contributed to the reported event and observed problems.Therefore, the most probable cause of the reported event is adverse event related to procedure.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22495472
• Report Number: 3005099803-2025-03256
• Device Sequence Number: 18262061
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: (01)08714729787372(17)250709(10)31978950
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K203162
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 07/09/2025
• Device Model Number: M00534280
• Device Catalogue Number: M00534280
• Device Lot Number: 0031978950
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 42 KG