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

Model Number	M00534270
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf a0401 captures the product investigation finding of catheter guide detached.Block h11: a naviflex delivery system was received for analysis.The advanix stent was not returned.Visual examination of the returned device identified the guide catheter detached and kinked; and the push catheter and pull wire bent.Additionally, the suture was detached and was not returned.Product analysis could not confirm the reported event of a suture deployment issue.The naviflex delivery system was returned without the suture, and the investigation findings do not lead to a definitive conclusion regarding the cause of the reported event.However, it was reported that the guidewire remained inside the patient during the attempted deployment.The advanix biliary stent with naviflex rx delivery system instructions for use (ifu) state: "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." in addition, the barb flap cover was not used during device insertion through the biopsy cap.Per the ifu: "slide the stent barb cover over the trailing barb to assist with stent introduction into the scope." these deviations from the ifu are the most likely reasons the stent could not be deployed.Both steps are essential for proper device operation, and omission of these steps likely contributed to the deployment failure.The additional damages observed on the delivery system were most likely caused by the application of excessive force during use.Procedural tortuosity may have contributed to difficulty in device retrieval, potentially placing the device in a position that required increased force, resulting in the observed guide catheter detachment.Furthermore, damage observed on the push catheter and pull wire is most likely consistent with excessive manipulation and/or force applied during the procedure.Therefore, the most probable root cause of the reported event is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliiary preloaded stent was to be implanted in the common bile duct to treat tight stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the stent would not deploy correctly as the suture did not fully release.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 inside 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." note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states: "slide the stent barb cover over the trailing barb to assist with stent introduction into the scope." note: this event has been deemed a reportable event based on the investigation finding of catheter guide break.

• 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: 24333553
• Report Number: 3005099803-2026-00591
• Device Sequence Number: 21270935
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: (01)08714729787365(17)270710(10)37081497
• 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): 02/13/2026

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: M00534270
• Device Catalogue Number: M00534270
• Device Lot Number: 0037081497
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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