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

Model Number	M00534710
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the investigation findings of catheter guide detached.Block h11: the advanix stent with naviflex delivery system was not returned as it was disposed of and therefore unavailable for evaluation.However, photographs were provided showing the used device in its pouch, with visible guide catheter detachment and kinking.Product analysis could not confirm the reported events of stent failure to deploy, suture break and suture deployment issue as the device was not returned for analysis.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion".The complainant also reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." the investigation concluded that the reported events and additional observed damages of catheter guide kinked and catheter guide detached cannot be determined without proper device evaluation.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was to be implanted in the duodenum to treat a stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent did not deploy.The introducer was inserted without the barb flap cover through the biopsy cap, and the guidewire was pulled back from the stent prior to deployment.The procedure was successfully completed using another device of the same model.There were no patient complications reported as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the instructions for use.Note: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed." the user did not follow the instructions for use.Note: this event has been deemed a reportable event based on the investigation finding of 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22790642
• Report Number: 3005099803-2025-03820
• Device Sequence Number: 8634217
• Product Code: FGE
• UDI-Device Identifier: 08714729787266
• UDI-Public: (01)08714729787266(17)270122(10)35808022
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/12/2025

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: M00534710
• Device Catalogue Number: M00534710
• Device Lot Number: 0035808022
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• 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