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

Model Number	M00534300
Medical Device Problem Codes	Break (1069); 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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the common bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the guidewire was unable to exit the rx port despite multiple attempts.The device was removed, and another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that the guide catheter was smashed.Please see block h11 for the full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter break.Block g4: k101314 pro code exceeded character limit for the designated field.Block h11: an advanix biliary stent was received for analysis.Visual inspection of the returned device found no damages.However, destructive test was performed, and it was observed that the guide catheter was smashed under microscope inspection.Functional inspection was performed, and it was observed that the guide catheter was difficult to advance and pull and it was difficult to advance/load the guidewire into the device.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of device difficult to advance guidewire as the guide catheter was difficult to advance and pull and it was difficult to advance/load the guidewire into the device during functional analysis.Taking all available information into consideration, the investigation concluded that the reported and observed events were likely due to procedural factors, such as improper handling or excessive manipulation during guidewire insertion, which may have caused the damage to the guide catheter.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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23429983
• Report Number: 3005099803-2025-05698
• Device Sequence Number: 15902291
• Product Code: FGE
• UDI-Device Identifier: 08714729787396
• UDI-Public: (01)08714729787396(17)270407(10)36742088
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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 Model Number: M00534300
• Device Catalogue Number: M00534300
• Device Lot Number: 0036742088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/30/2025
• 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: Unknown