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	03/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex delivery system was to be implanted during a procedure performed on (b)(6) 2025.During the procedure, the black inner sheath was separated during deployment.There was no patient complication reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Blocks b1, b5, h1, and h6 (impact codes) have been updated with the additional information received on march 27, 2025.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdr impact code f2301 captures the used of snares to remove the broken guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex delivery system was to be implanted during a procedure performed on (b)(6) 2025.During the procedure, the black inner sheath was separated during deployment.There was no patient complication reported as a result of this event.Note: no further information has been obtained despite good faith efforts.Additional information received on march 27, 2025.It was reported that the advanix stent with naviflex delivery system was to be implanted in the biliary duct to treat a biliary stricture during an endoscopic retrograde biliary drainage (erbd) procedure.The detached black inner sheath was removed using a snare and another naviflex delivery system was used to complete the procedure.
Additional Manufacturer Narrative
Blocks b1, b5, h1, and h6 (impact codes) have been updated with the additional information received on march 27, 2025.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdr impact code f2301 captures the used of snares to remove the broken guide catheter.Block h11: the advanix-naviflex biliary stent was returned for analysis.Visual examination of the returned device found that the pull wire was kinked, and the guide catheter wasn't visible.A destructive test was performed, the guide catheter was detached from the pull wire hypo tube, the guide catheter wasn't returned.No other problems were noted to the stent and delivery system.The reported event of catheter guide break was confirmed.Taking all available information into consideration, the investigation concluded that the reported event and observed failures were likely due to factors encountered during the procedure.It is possible that tortuosity, handling of the device and the technique used by the physician, limited the performance of the device and contributed to the reported event and observed failures.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex delivery system was to be implanted during a procedure performed on (b)(6) 2025.During the procedure, the black inner sheath was separated during deployment.There was no patient complication reported as a result of this event.Note: no further information has been obtained despite good faith efforts.***additional information received on march 27, 2025*** it was reported that the advanix stent with naviflex delivery system was to be implanted in the biliary duct to treat a biliary stricture during an endoscopic retrograde biliary drainage (erbd) procedure.The detached black inner sheath was removed using a snare and another naviflex delivery system was used to complete the procedure.

• 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: 21724086
• Report Number: 3005099803-2025-01306
• Device Sequence Number: 3808430
• 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,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 0035217744
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 05/20/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/21/2025; 06/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown