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

Model Number	M00534290
Medical Device Problem Codes	Break (1069); 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	06/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be implanted in the bile duct to treat a bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black inner core of the stent could not move along the operating wire, preventing the device from reaching the target position.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient remained stable post-procedure.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 physician did not follow the steps cited in the ifu.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the flexima biliary stent with delivery system instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): the initial reporter facility name is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Additional Manufacturer Narrative
Blocks b5 and g2 have been corrected.Block e1 (initial reporter facility name): the initial reporter facility name is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be implanted in the bile duct to treat a bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black inner core of the stent could not move along the operating wire, preventing the device from reaching the target position.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient remained stable post-procedure.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." in addition, it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix-naviflex biliary stent instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Blocks b5 and g2 have been corrected.Block e1 (initial reporter facility name): the initial reporter facility name is (b)(6) university.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: an advanix biliary stent was received for analysis.Visual examination of the returned device revealed that the stent was damaged.However, the guide catheter was not broken.During functional testing, the guide catheter was successfully retracted and extended without any issues.Product analysis did not confirm the reported event of catheter guide breakage, as the guide catheter was intact and functioned properly during testing.Although the stent was returned in a damaged condition, this damage occurred during the procedure, and there is no objective evidence or descriptive context to confirm the cause.Furthermore, the instructions for use (ifu) were not followed, which is likely the reason the stent was found damaged.Specifically, some procedural steps were skipped: the guidewire remained inside the patient during attempted deployment, and the barb flap cover was not used to insert the device through the biopsy cap.Based on a review and analysis of all available information, the most probable cause of the reported event is no problem detected.A labeling review was also performed.From the information available, it was determined that the device was used in a manner inconsistent with the ifu/product label.The complainant reported that the barb flap cover was not used during insertion through the biopsy cap.According to the ifu, the outer orange sleeve should be slid over the most proximal stent barb to hold it down for stent insertion.Additionally, the ifu includes a warning that if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.In this case, it was reported that the guidewire remained inside the patient during the attempted deployment.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was to be implanted in the bile duct to treat a bile duct stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black inner core of the stent could not move along the operating wire, preventing the device from reaching the target position.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event and the patient remained stable post-procedure.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." in addition, it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix-naviflex biliary stent instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luer-lok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.

• 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: 22469953
• Report Number: 3005099803-2025-03170
• Device Sequence Number: 20953695
• Product Code: FGE
• UDI-Device Identifier: 08714729787389
• UDI-Public: (01)08714729787389(17)260715(10)34677390
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2025

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 Expiration Date: 07/15/2026
• Device Model Number: M00534290
• Device Catalogue Number: M00534290
• Device Lot Number: 0034677390
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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 Age: 49 YR
• Patient Sex: Male
• Patient Weight: 63 KG