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

Model Number	M00534280
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used in the ductus choledochus for a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the stent could not be deployed.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 patient 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 can not be fully deployed." the physician did not follow the steps cited in the ifu.Furthermore, 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." note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the snare loop was detached.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter detached.Block h11: an advanix biliary stent with naviflex rx delivery system was returned for analysis.Visual examination of the returned device was returned without a part of the pull wire, the stent suture hole was torn, and the guide catheter was detached.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy and as the guide catheter returned detached.Furthermore, the device was returned without a part of the pull wire, the stent suture hole was torn, and the guide catheter was detached.These damages may have occurred if the device was under pressure during stent deployment, possibly due to the physician's technique or the anatomical tortuosity encountered during the procedure.It is most likely that the device was unable to deploy the stent, and the pressure exerted on the suture caused damage to the suture hole.There is also a possibility that the same force applied during the attempted deployment caused the guide catheter and a portion of the pull wire to detach during the procedure.Therefore, a review and analysis of the all the available information indicated that the most probable cause is failure to follow instructions.A product labeling review identified that the device may have been used in a manner inconsistent with the labeled indications.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." however, it was reported that the guidewire remained inside the patient during the attempted deployment.It was also 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." these deviations from the ifu specifically, leaving the guidewire inside the patient during the attempted deployment and not using the barb flap cover for insertion are the most likely reasons the stent could not be deployed.Both steps are essential for proper operation of the device and skipping them likely contributed to the deployment failure.

• 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: 24242307
• Report Number: 3005099803-2026-00421
• Device Sequence Number: 21376255
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: (01)08714729787372(17)261031(10)35418674
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 02/02/2026

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: M00534280
• Device Catalogue Number: M00534280
• Device Lot Number: 0035418674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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