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

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter - guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx delivery system was to be implanted to treat common bile duct stenosis in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the physician was about to deploy the stent at the lesion site, the delivery system fractured, resulting in the failure of stent deployment.The issue was noticed during withdrawal, and the problem occurred inside the patient.Another advanix-naviflex rx delivery system was used to complete the procedure there were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the ifu; therefore, this complaint has been assigned ar code 5191: 2457 to capture user error.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx delivery system was to be implanted to treat common bile duct stenosis in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the physician was about to deploy the stent at the lesion site, the guide catheter broke but still remains within the push catheter, enabling the delivery system to be removed in one piece resulting in the failure of stent deployment.The issue was noticed during withdrawal, and the problem occurred inside the patient.Another advanix-naviflex rx delivery system was used to complete the procedure there were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the ifu.
Additional Manufacturer Narrative
Blocks b5 have been corrected.Block e1: initial reporter facility name: (b)(6) university.Block h6: imdrf device code a0401 captures the reportable event of catheter - guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx delivery system was to be implanted to treat common bile duct stenosis in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the physician was about to deploy the stent at the lesion site, the guide catheter broke but still remains within the push catheter, enabling the delivery system to be removed in one piece resulting in the failure of stent deployment.The issue was noticed during withdrawal, and the problem occurred inside the patient.Another advanix-naviflex rx delivery system was used to complete the procedure there were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the ifu, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the user did not follow the ifu.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of catheter - guide break.Block h11: an advanix-naviflex delivery system was returned for analysis.A visual examination of the returned device revealed that the guide catheter was detached, the pull wire was bent, and both the guide catheter and the push catheter exhibited kinking.No other damages were noted to the delivery system.Product analysis confirmed the reported event of guide catheter break.Taking all available information into consideration, the investigation concluded that the reported event and observed damage most likely resulted from the device being pulled with excessive force; the procedures tortuosity may have positioned the catheter so that forceful traction damaged the pull wire and push catheter, making stent deployment difficult or impossible.Therefore, a review and analysis of all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the labeled indications.Slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion, however, it was reported that the barb flap cover was not used to insert the device through the biopsy cap.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.

• 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: 22974319
• Report Number: 3005099803-2025-04525
• Device Sequence Number: 18526773
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)260314(10)33635135
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/14/2025

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: 03/14/2026
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0033635135
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/05/2025; 10/22/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/30/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 73 KG