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

Model Number	M00534230
Medical Device Problem Codes	Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of catheter guide break.Block h11: an advanix biliary stent with naviflex rx delivery system was returned for analysis.Visual examination of the returned device found the push catheter and stent suture hole were torn.Functional testing confirmed that the guide catheter was detached.A destructive test was performed, and it was observed that the hypotube was in good conditions.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy and as the guide catheter returned detached.The investigation concluded that the reported event and additional observed damages were most likely related to procedural factors, as device handling and the technique used by the physician (including the force applied) could have contributed to the observed problems.Additionally, functional testing determined that the guide catheter was detached.This event was likely due to a quality control deficiency, as it was found that the pull wire had not been assembled deeply enough into the black guide catheter.Boston scientific initiated a non-conforming events prevention (ncep) investigation in june 2024 to further evaluate "catheter guide break" events where the hypotube was not properly bonded to the inside of the guide catheter.The investigation found the guide catheter can slip within the grippers during the bonding cycle after the foot pedal is pushed to begin the cycle.If this is not identified during visual inspection by the operator, this can cause an insufficient bond between hypotube and guide catheter.An immediate action was taken to add a magnification tool to the manufacturing process to improve operator visualization of the bond during the required inspection, and all operators were reminded of the correct method for bond inspections.Although the advanix biliary stent with naviflex rx delivery system continues to perform within anticipated product performance expectations, boston scientific initiated a corrective and preventive action (capa) investigation to further investigate whether any additional corrective actions are warranted.Therefore, a review and analysis of the all the available information indicated that the most probable cause is quality control deficiency.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent did not release from the delivery device.The procedure was completed with another of the same device.There were no patient complications as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the guide catheter was detached.Please see block h11 for full investigation details.

• 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: 24205651
• Report Number: 3005099803-2026-00345
• Device Sequence Number: 9635604
• Product Code: FGE
• UDI-Device Identifier: 08714729787327
• UDI-Public: (01)08714729787327(17)270407(10)36336264
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• 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
• Report Date (Section B): 01/28/2026

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: M00534230
• Device Catalogue Number: M00534230
• Device Lot Number: 0036336264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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: Male