MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NaviFlex? RX Delivery System; Catheter, Biliary, Diagnostic

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction

• 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 ; +1(914)571-6918
• MDR Report Key: 50057608
• Report Number: 3005099803-2026-03062
• Device Sequence Number: 9349721
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)271106(10)38019809
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 0038019809
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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
• Patient Sex: Unknown