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

Model Number	M00534320
Medical Device Problem Codes	Break (1069); Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached/separated.Block h11: an advanix-naviflex biliary stent was returned for analysis.A visual examination of the returned device revealed that the suture and guide catheter were not present, as they had detached from the system.No other damages were noted to the stent and delivery system.Product analysis was not confirmed the reported event of the stent premature deployment; however, the suture break and guide catheter break can be confirmed.Since the suture was not returned, only the delivery system was returned.The reported event and additional observed damages were most likely a result of the device being pulled with too much force, perhaps the tortuosity of the procedure put the device in a position in which it was hard to pull the guide catheter.Therefore, it is not possible to determine if this part had any sort of damage that would have affected the stent deployment.Taking all available information into consideration, the overall root cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be implanted to treat choledocholithiasis in the vateri papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the insertion process, the thread on the delivery system became loose without any retraction of the wire by the user.As a result, the stent detached prematurely and fell off.Another advanix-naviflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation findings of inner guide catheter detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached/separated.Block h11: an advanix-naviflex biliary stent was returned for analysis.A visual examination of the returned device revealed that the suture and guide catheter were not present, as they had detached from the system.No other damages were noted to the stent and delivery system.Product analysis was not confirmed the reported event of the stent premature deployment; however, the suture break and guide catheter break can be confirmed.Since the suture was not returned, only the delivery system was returned.The reported event and additional observed damages were most likely a result of the device being pulled with too much force, perhaps the tortuosity of the procedure put the device in a position in which it was hard to pull the guide catheter.Therefore, it is not possible to determine if this part had any sort of damage that would have affected the stent deployment.Taking all available information into consideration, the overall root cause is cause not established.A labeling review was performed and, from the information available.The instruction for use (ifu) contains detailed device information and instructions for the device use.There is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be implanted to treat choledocholithiasis in the vateri papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the insertion process, the thread on the delivery system became loose without any retraction of the wire by the user.As a result, the stent detached prematurely and fell off.Another advanix-naviflex biliary stent was used to complete the procedure there were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation findings of inner guide catheter 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: 23717671
• Report Number: 3005099803-2025-06552
• Device Sequence Number: 21044235
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: (01)08714729787419(17)261028(10)35210874
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/16/2025

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: M00534320
• Device Catalogue Number: M00534320
• Device Lot Number: 0035210874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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