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

Model Number	M00534330
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 capture the reportable event of guide catheter break based on the product investigation.Block h11: the advanix rx biliary preloaded db stent was returned for evaluation.Visual inspection showed the device was returned without the suture, which had detached.Microscopic inspection revealed torn suture holes in both the stent and the push catheter.The guide catheter was also returned detached.Product analysis confirmed the reported event of stent failure to deploy.The investigation determined that the stent was not deployed because the instructions for use (ifu) were not followed.It was reported that the guidewire was in the bile duct during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system ifu states: "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." this step was not followed.Further analysis indicated that the torn suture holes are consistent with excessive force applied during deployment, potentially due to physician technique and/or procedural tortuosity.Resistance during deployment likely increased tension on the suture, preventing release of the stent and resulting in damage to the suture holes and suture detachment.The detached guide catheter is also consistent with excessive pulling force during the procedure, possibly related to challenging anatomy.Therefore, based on all available information into consideration, the investigation selected the most probable cause of failure to follow instructions.A labeling review was performed and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded stent was to be implanted in the common bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2025.During the procedure, the stent failed to separate from the delivery system.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the bile duct during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the physician did not follow the steps cited in the ifu.Note: this event has been deemed a reportable event based on the investigation finding of catheter guide detached or separated.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: 23835600
• Report Number: 3005099803-2025-06774
• Device Sequence Number: 20081821
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: (01)08714729787426(17)270811(10)37243870
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

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: M00534330
• Device Catalogue Number: M00534330
• Device Lot Number: 0037243870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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