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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.The complainant was unable to provide the complaint device upn and lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was used during a stent placement procedure performed on (b)(6) 2025.During the procedure, the advanix biliary stent was released but the guide catheter remained attached.It was necessary to pull as it was stuck to the endoscope.The guide catheter was then detached, and the stent was pushed back.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b5, d4 (model number, lot number, catalog number, expiration date, unique identifier (udi) #), d6a (implant date), h4 (device manufacture date), and h6 (device code) were corrected following a review that determined that the device involved was an advanix rx bili preload db.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: a naviflex delivery system was received for analysis.Visual inspection found the guide catheter detached and bent, and the push catheter bent.No other problems were noted with the delivery system.Product analysis confirmed the reported events of catheter guide break and stent difficult to position due to the condition in which the delivery system was returned.The investigation concluded that the catheter guide most likely broke as a result of the device being pulled with excessive force, or the procedure's tortuosity may have placed the device in a position that made guide catheter retrieval difficult.The resulting force likely damaged the push catheter and caused it to bend.This damage may have prevented proper stent placement/positioning and created difficulties during the procedure.Therefore, the most probable cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded db stent was implanted during a stent placement procedure performed on (b)(6) 2025.During the procedure, the advanix biliary stent was released but the navilflex delivery system guide catheter remained attached.It was necessary to pull as it was stuck to the endoscope.The guide catheter was then detached, and the stent was pushed back.There were no patient complications reported as a result of this event.

• 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: 22854186
• Report Number: 3005099803-2025-04245
• Device Sequence Number: 14557682
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: (01)08714729787433(17)270303(10)36092664
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: M00534340
• Device Catalogue Number: M00534340
• Device Lot Number: 0036092664
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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