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

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation findings of catheter guide break and pull wire break.Block h11: the naviflex delivery system was received for analysis.Visual examination of the returned device found the guide catheter detached, and the pull wire detached and kinked.No other damages were noted to the delivery system.Product analysis did not confirm the reported event of device difficult to set up or prepare as this event happened during the procedure and it is not possible to be replicated in the laboratory of analysis.The investigation concluded that the additional observed damages of catheter guide break, pull wire break and pull wire kinked were most likely due to procedural factors as handling of the device and the technique used by the physician (force applied).Therefore, the most probable cause of the reported event and additional observed damages is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be implanted in the bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed (b)(6) 2025.It was reported that there were defects connecting the naviflex delivery system with the advanix stent.Another of the same device 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 the guide catheter and pull wire were broken.Please see block h11 for the full investigation details.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22071231
• Report Number: 3005099803-2025-02335
• Device Sequence Number: 9301483
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)261022(10)35217744
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0035217744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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