MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX? RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used to treat cholangiocarcinoma stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, it was reported that the deployment system broke, leaving the introducer in the stent.The device was then removed, and the procedure was completed with another stent of the same type.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: the advanix-naviflex delivery system was not returned for evaluation; therefore, a physical product analysis could not be performed.However, the customer provided documentation that included photographs of the device.A media analysis was conducted based on these images.The photographs revealed that the stent was outside of its pouch after use.From the images, it was possible to identify that the guide catheter appeared bent, broken, and detached.Media analysis cannot confirm the reported event of guide catheter break.The customer provided some pictures where it can be observed that the guide catheter appeared bent or kinked and detached; however, without proper evaluation of the device it remains unknown the most probable causes that contributed to the event.There is not enough evidence to determine if the reported event was related to the physician's technique during the procedure, due to the anatomical conditions or related to a device malfunction.Taking all available information into consideration, the most probable cause of the reported event is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used to treat cholangiocarcinoma stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tight prior to stent placement.During the procedure, it was reported that the deployment system broke, leaving the introducer in the stent.The device was then removed, and the procedure was completed with another stent of the same type.There were no patient complications reported as a result of this event.

• Brand Name: NAVIFLEX? RX DELIVERY SYSTEM
• 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: 23342370
• Report Number: 3005099803-2025-05361
• Device Sequence Number: 7771251
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)270716(10)37097389
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0037097389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female