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

Model Number	M00535060
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted to treat strictures during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the guiding catheter became lodged in the stent, preventing successful device deployment.In addition, the suture loop was not able to exit the guide catheter.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation finding of guide catheter detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event, as no event date was reported.Block h6: imdrf device code a0401 captures the reportable event of catheter guide detached/separated.Block h11: the naviflex rx pancreatic delivery system was returned for analysis.Visual inspection revealed damage to the push catheter, a kinked pull wire, and a detached guide catheter.Functional testing confirmed that the pull wire could not be retracted.No other damage was observed on the device.The reported pull wire retraction was confirmed, as it was not possible to retract the pull wire during the product investigation.The investigation concluded that the observed damages, such as the kinked pull wire and damage to the push catheter were most likely caused by procedural factors, including the handling of the device and the technique used by the physician (specifically, the amount of force applied).These factors likely contributed to the difficulty in retracting the pull wire.Additionally, the guide catheter was returned in a detached condition.It is likely that this occurred as a result of excessive force being applied while attempting to remove the device.The procedural tortuosity may have positioned the device in such a way that pulling the guide catheter became difficult, and the applied force may have led to its detachment.Taking all available information into consideration, the most probable cause of is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu) / product label.

• 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: 22819818
• Report Number: 3005099803-2025-04084
• Device Sequence Number: 17577315
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: (01)08714729856221(17)260612(10)35710175
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K133700
• 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
• Report Date (Section B): 08/15/2025

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: 06/12/2026
• Device Model Number: M00535060
• Device Catalogue Number: M00535060
• Device Lot Number: 0035710175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/15/2025
• Date Device Manufactured: 12/11/2024
• 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