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

Model Number	M00534630
Medical Device Problem Codes	Positioning Failure (1158); Retraction Problem (1536); 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	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a advanix-naviflex rx biliary stent was to be implanted to treat a common bile duct (cbd) stricture in the section portion of duodenal, next to papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure the technician noted that pulling the rear wire did not advance the stent.Upon inspection, the locking mechanism was confirmed to be in the unlocked position.Another advanix-naviflex rx biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that guide catheter was detached.Please see block h11 for the full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a advanix- naviflex biliary rx stent was received for analysis.Visual examination of the returned device found the guide catheter detached, the push catheter was observed kinked, the stent suture hole was torn, and the stent was kinked.Functional inspection was performed; it wasn't possible to retract or the pull wire.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy, pull wire retraction problem, use of device issue - user error.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.The labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion".However, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Therefore, the most probable root cause is failure to follow instructions.
Additional Manufacturer Narrative
Block e1: initial reporter email was updated with the physician's email.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a advanix- naviflex biliary rx stent was received for analysis.Visual examination of the returned device found the guide catheter detached, the push catheter was observed kinked, the stent suture hole was torn, and the stent was kinked.Functional inspection was performed; it wasn't possible to retract or the pull wire.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy, pull wire retraction problem, use of device issue - user error.The investigation concluded that the reported event and additional observed damages were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.The labeling review found evidence to suggest that the device was used in a manner inconsistent with the labelled indications.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion".However, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Therefore, the most probable root cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that a advanix-naviflex rx biliary stent was to be implanted to treat a common bile duct (cbd) stricture in the section portion of duodenal, next to papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure the technician noted that pulling the rear wire did not advance the stent.Upon inspection, the locking mechanism was confirmed to be in the unlocked position.Another advanix-naviflex rx biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: this complaint has been deemed mdr reportable event based on the investigation result which revealed that guide catheter was detached.Please see block h11 for the 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: 22804607
• Report Number: 3005099803-2025-03972
• Device Sequence Number: 12721863
• Product Code: FGE
• UDI-Device Identifier: 08714729787181
• UDI-Public: (01)08714729787181(17)261031(10)35276986
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 09/18/2025

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: M00534630
• Device Catalogue Number: M00534630
• Device Lot Number: 0035276986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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