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

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break and pull wire break.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex delivery system was to be implanted in the biliary site to treat biliary stricture during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the black inner sheath broke and was removed using forceps.Another naviflex delivery system was used to complete the procedure there were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: a naviflex delivery system was returned for analysis.Visual examination of the returned device revealed no observable damage.The guide catheter was intact, with no signs of breakage or detachment.It was possible to retract and extend the guide catheter without any issues.Functional testing was performed and confirmed that the device operated within expected parameters.No damage was noted on the delivery system.Product analysis did not confirm the reported event of catheter break.Taking all available information into consideration, the investigation concluded that there was no objective evidence to support the reported issue, as no defect or malfunction was identified on the returned device.Therefore, a review and analysis of the available information indicated that the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was to be used to implant a plastic stent in the biliary site to treat a biliary stricture during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2025.During the procedure, the black inner sheath broke and was removed using forceps.Another naviflex delivery system was used to complete the procedure.There were no patient complications 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: 23030696
• Report Number: 3005099803-2025-04614
• Device Sequence Number: 18498809
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)260828(10)34735257
• 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,Followup
• Report Date (Section B): 11/04/2025

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: 08/28/2026
• Device Model Number: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0034735257
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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