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

Model Number	M00534270
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was intended to be implanted to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, when attempting to deploy the stent, the nurse retracted the stylet fully until the green marker was visible.The physician then pulled the guidewire; however, the stent did not deploy.It was noted that the black introducer did not move, suggesting that the metal stylet may have detached internally or otherwise prevented the introducer from retracting.As a result, the entire scope had to be removed because deployment could not be achieved.A second advanix naviflex biliary stent was used to successfully complete the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was intended to be implanted to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, when attempting to deploy the stent, the nurse retracted the stylet fully until the green marker was visible.The physician then pulled the pulllwire; however, the stent did not deploy.It was noted that the black introducer did not move, suggesting that the metal stylet may have detached internally or otherwise prevented the introducer from retracting.As a result, the entire scope had to be removed because deployment could not be achieved.A second advanix naviflex biliary stent was used to successfully complete the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
A sentence on block b5 (describe event or problem) has been corrected - "the physician pulled the pullwire" block h6: imdrf device code a0401 captures the reportable event of catheter break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Block h11: investigation results: boston scientific corporation could not confirm the reported event of catheter guide break and stent failure to deploy.The device was not returned; therefore, product analysis could not be performed.Based on the information available and without proper evaluation of the device, it remains unknown the most probable causes that contributed to the events.Device history record review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which have contributed to the reported event device technical analysis: the device was not returned; therefore, product analysis could not be performed.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 unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was intended to be implanted to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, when attempting to deploy the stent, the nurse retracted the stylet fully until the green marker was visible.The physician then pulled the pulllwire; however, the stent did not deploy.It was noted that the black introducer did not move, suggesting that the metal stylet may have detached internally or otherwise prevented the introducer from retracting.As a result, the entire scope had to be removed because deployment could not be achieved.A second advanix naviflex biliary stent was used to successfully complete the procedure.No patient complications were reported 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: 24317361
• Report Number: 3005099803-2026-00566
• Device Sequence Number: 17359272
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: (01)08714729787365(17)271014(10)37874306
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 03/25/2026

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: M00534270
• Device Catalogue Number: M00534270
• Device Lot Number: 0037874306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 01/20/2026; 02/27/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/13/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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