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

Model Number	M00533580
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	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the detached catheter was removed using rat tooth forceps.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used during a stent placement procedure performed on an unknown date.During the procedure, the black catheter remained in the prosthesis after deployment.The detached catheter was removed using rat tooth forceps, and the procedure was completed.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
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the detached catheter was removed using rat tooth forceps.Block h11: a naviflex rx delivery system was received for analysis.The guide catheter was not returned; it had been detached from the device.The pull wire was found stuck, as it was not possible to introduce it again for a functional test.Product analysis confirmed the reported event of catheter guide break.The reported event and the additional observed event of a stuck pull wire were most likely related to procedural factors such as lesion characteristics, device handling, and the technique used by the physician.It is possible that during stent deployment, vessel tortuosity or the physician's technique caused the guide catheter to detach from the pull wire.Additional force may have been applied while attempting to deploy the stent.Consequently, the pull wire became stuck and extended too far from the handle, preventing reinsertion for functional testing.Therefore, the most probable cause of the reported event 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.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used during a stent placement procedure performed on an unknown date.During the procedure, the black catheter remained in the prosthesis after deployment.The detached catheter was removed using rat tooth forceps, and the procedure was completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• 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: 22056618
• Report Number: 3005099803-2025-02187
• Device Sequence Number: 7156843
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)260719(10)34470053
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Expiration Date: 07/19/2026
• Device Model Number: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0034470053
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown