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

Model Number	M00533580
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	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that naviflex rx delivery system was used in the ampulla to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, it was reported that the device was broken or fractured.It was noted that the end part of the pusher that guides that stent was frayed.Subsequently, the pusher was removed through the biopsy cap.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that naviflex rx delivery system was used in the ampulla to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, it was reported that the device was broken or fractured.It was noted that the end part of the pusher that guides that stent was frayed.Subsequently, the pusher was removed through the biopsy cap.The procedure was completed with another of the same device.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 guide catheter break.Block h11: an advanix naviflex delivery system was returned for analysis.A visual examination of the returned device revealed that the push catheter was bent, and the guide catheter exhibited damage in the form of small kinks at its distal end.Functional testing was performed, and it was possible to extend and retract the guide catheter without restriction.Product analysis could not confirm the reported event of a catheter guide break.Examination of the returned device identified damage to both the push catheter and the guide catheter.The push catheter was found to be bent, while the guide catheter displayed small kinks near the distal end.Despite these damages, the guide catheter could still be extended and retracted during functional testing.Taking all available information into consideration, the investigation concluded that the reported event and the observed damage were most likely related to factors such as device handling, insertion technique, or the amount of force applied by the physician during scope insertion or device preparation.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23302457
• Report Number: 3005099803-2025-05357
• Device Sequence Number: 10028397
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)270723(10)37060928
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/09/2026

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: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0037060928
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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