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

Model Number	M00534700
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	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used for stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During stent preparation, the nurse attempted to retract the black inner catheter using the pull wire.The wire pulled back, but the inner catheter did not retract.The pull wire was then pushed back in and the attempt repeated; however, the catheter again did not retract.The device was confirmed to be in the unlocked position.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: investigation summary: based on the available information, boston scientific corporation confirmed the reported event of catheter guide break.This conclusion is supported by visual examination, which identified a detached guide catheter, and microscopic inspection, which revealed a fracture at the junction between the pull wire and the hypotube.The investigation determined that the detachment of the guide catheter was most likely due to a random failure at the connection between the pull wire and the hypotube during the procedure.The fracture was localized at the pull wire joint.This pull wire component is not manufactured or modified during spencer manufacturing processes.In addition, downstream assembly operations include multiple actuation steps involving advancement and retraction of the guide catheter; therefore, a pre-existing fracture at this joint would likely have been detected during in-process inspections.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 rx biliary stent with naviflex delivery system was returned for analysis.Visual examination confirmed that the guide catheter was detached.Microscopic inspection identified a fracture at the junction between the pull wire and the hypotube.No additional abnormalities or device issues were observed.Risk review: a risk review was completed and confirmed that the event of catheter guide break 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 was used for stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During stent preparation, the nurse attempted to retract the black inner catheter using the pull wire.The wire pulled back, but the inner catheter did not retract.The pull wire was then pushed back in and the attempt repeated; however, the catheter again did not retract.The device was confirmed to be in the unlocked position.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 23985502
• Report Number: 3005099803-2026-00071
• Device Sequence Number: 17300841
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: (01)08714729787259(17)270801(10)37155715
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: M00534700
• Device Catalogue Number: M00534700
• Device Lot Number: 0037155715
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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