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

Model Number	M00534290
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the biliary tract to treat biliary obstruction during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the connection point between the advancer and the stent was fractured, preventing successful deployment.Another of the same device was used to complete the procedure.There were no patient complications due to this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter - guide break.
Additional Manufacturer Narrative
Blocks b1, b2, b5, e1 and h1, h2 and h6 have been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter - guide break.Imdr impact code f2301 captures the used of snares to remove the broken guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the biliary tract to treat biliary obstruction during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the connection of the advancer and the stent was fractured, and the stent could not be deployed, and the broken guide catheter was removed using snares.Another of the same device was used to complete the procedure.There were no patient complications due to this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter - guide break.Imdr impact code f2301 captures the used of snares to remove the broken guide catheter.Block h11: an advanix-naviflex biliary stent and delivery system was returned for analysis.Visual examination revealed that the guide catheter was bent but remained attached to the device.Functional inspection confirmed that the guide catheter could be retracted and extended without any issues.Microscopic inspection was performed the push catheter suture hole was observed torn.No other problems were noted with the stent or the delivery system.Taking all available information into consideration, the investigation concluded that the reported event guide catheter detached cannot be confirmed.And stent failure to deploy was confirmed.The push catheter suture hole was observed torn.It may be that the position of the device when it was placed inside the patient, the tortuosity encountered during the procedure, the force applied and/or the technique used by the physician, limited the performance of the device and contributed to observed damages.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the biliary tract to treat biliary obstruction during endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the connection of the advancer and the stent was fractured, and the stent could not be deployed, and the broken guide catheter was removed using snares.Another of the same device was used to complete the procedure.There were no patient complications due to this event.The patient condition following the procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22471974
• Report Number: 3005099803-2025-03217
• Device Sequence Number: 4172354
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389(17)250808(10)32184177
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2025
• Device Model Number: M00534290
• Device Catalogue Number: M00534290
• Device Lot Number: 0032184177
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 08/07/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 07/30/2025; 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 54 KG