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

Model Number	M00534320
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block h11: investigation results: based on the available information, boston scientific corporation confirmed the reported event of stent failure to deploy due to the additional damage found on the device that most likely impeded appropriate stent deployment.The investigation concluded that the additional observed events of guide catheter break and system damage were caused by a fracture at the connection between the hypotube and pull wire, identified during microscopic inspection, which most likely occurred as a random component failure during the procedure and resulted in detachment of the guide catheter.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: an advanix biliary stent with naviflex delivery system was received for analysis.Visual inspection identified no observable damage.However, the guide catheter was found detached from the catheter assembly upon receipt.Microscopic examination of the device confirmed a fracture at the joint between the hypotube and the pull wire.No additional issues were observed in the device.Labeling review: a labeling review was performed and, from the information available, this device was used in a manner inconsistent with the instructions for use (ifu) / product label.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu "slide the stent barb cover over the trailing barb to assist with stent introduction into the scope." risk review: a risk review was completed and confirmed that the event of catheter guide detached/separated was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause traced to component failure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was used during an endoscopic retrograde balloon dilation (erbd) procedure performed on (b)(6) 2026.During the procedure, the plastic stent failed to separate.The procedure was completed with another of the same device.There were no patient complications reported as a results of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the stent barb cover over the trailing barb to assist with stent introduction into the scope." the user did not follow the ifu.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: 24983050
• Report Number: 3005099803-2026-01509
• Device Sequence Number: 9698938
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: (01)08714729787419(17)260304(10)33552364
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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 Expiration Date: 03/04/2026
• Device Model Number: M00534320
• Device Catalogue Number: M00534320
• Device Lot Number: 0033552364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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