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

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the pull wire cap of the naviflex delivery system popped off, and the guide catheter and pull wire were kinked and broken.Hemostats were used to finish the deployment, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable events of guide catheter break and pull wire break.
Additional Manufacturer Narrative
Block b5 was updated based on the additional information received on may 08, 2025.Block h6: imdrf device code a0401 captures the reportable events of guide catheter break and pull wire break.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2025.During the procedure, the pull wire cap of the naviflex delivery system popped off, and the guide catheter and pull wire were kinked and broken.Hemostats were used to finish the deployment, and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on may 08, 2025, it was reported that the naviflex rx delivery system was used in the pancreatic duct.The stent was successfully deployed without problem.

• 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: 21964033
• Report Number: 3005099803-2025-01983
• Device Sequence Number: 15750235
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)260918(10)34879112
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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 Expiration Date: 09/18/2026
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0034879112
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/08/2025; 05/25/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/28/2025; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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: Unknown