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

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a naviflex delivery system was to be implanted to the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the naviflex guide catheter moved even in locked mode, as it was reportedly broken.The broken guide catheter remained within the push catheter enabling the delivery system to be removed in one piece.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the naviflex rx delivery system instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luerlok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Block e1 initial reporter phone has been updated based on the additional information that was received on august 21, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was to be implanted to the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the naviflex guide catheter moved even in locked mode, as it was reportedly broken.The broken guide catheter remained within the push catheter enabling the delivery system to be removed in one piece.The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the naviflex rx delivery system instructions for use (ifu) states, "to deploy the stent, loosen the tuohy-borst adapter slightly and pull on the guide catheter luerlok hub and guidewire.Hold the outer positioner stationary, while gently retracting the inner guide catheter and guidewire.Endoscopically monitor the stent position.Warning if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.

• 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: 22958029
• Report Number: 3005099803-2025-04448
• Device Sequence Number: 15850838
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)261011(10)35098070
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0035098070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 01/13/2026
• Date Device Manufactured: 10/11/2024
• 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: Male