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

Model Number	M00533580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter city and state: (b)(6).Initial reporter phone number: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required to remove the detached guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx delivery system was to be implanted to treat biliary obstruction caused by stones in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black introducer failed to fully withdraw and became stuck in the stent.It then detached from the wire pull system, leaving the black introducer component inside the stent and it was removed using forceps.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block b5 was corrected with the appropriate complaint device name block e1: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of additional device required to remove the detached guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used to implant a plastic stent to treat a biliary obstruction caused by stones in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black introducer failed to fully withdraw and became stuck in the stent.It then detached from the pull wire system, leaving the black introducer component inside the stent and it was removed using forceps.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: 23414495
• Report Number: 3005099803-2025-05542
• Device Sequence Number: 10269038
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)270606(10)36756047
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0036756047
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 06/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 56 KG