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	09/30/2025
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 a naviflex rx delivery system was to be used during an endoscopic retrograde biliary drainage (erbd) with stent implant procedure performed on (b)(6), 2025.During the procedure, it was observed that the inner sheath of the device was separated.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: a naviflex delivery system was returned for analysis.A visual examination of the returned device found the guide catheter detached from the device.Additionally, the pull wire and the guide catheter were kinked.Microscopic examination was performed, during which the hypotube was observed to be in good condition with no signs of structural damage or deformation.Product analysis confirmed the reported event of catheter guide break.The investigation determined that the reported event and additional observed damage were most likely caused by conditions encountered during the procedure.Both the guide catheter and the pull wire were found kinked, and the guide catheter detached during the procedure.The guide catheter may have become lodged within the push catheter or the endoscope.Attempts to free the device, potentially involving the application of excessive force, may have resulted in further kinking of the pull wire while the guide catheter remained entrapped.These conditions most likely led to detachment of the guide catheter during the procedure.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 a naviflex rx delivery system was to be used during an endoscopic retrograde biliary drainage (erbd) with stent implant procedure performed on (b)(6) 2025.During the procedure, it was observed that the inner sheath of the device was separated.There were no patient complications as a result of this event.

• 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: 23367090
• Report Number: 3005099803-2025-05528
• Device Sequence Number: 10122485
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)270506(10)36506117
• 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
• Report Date (Section B): 01/12/2026

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: 0036506117
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown