MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NaviFlex? RX Delivery System; catheter, biliary, diagnostic

Model Number	M00535060
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	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used to implant a stent in the pancreatic duct to treat a stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the tip of the guide catheter detached.The detached guide catheter tip was retrieved using forceps.No device fragments remained inside the patient's body, and the procedure was completed using the original device.There were no patient complications reported as a results of this event.
Additional Manufacturer Narrative
Block e1 (initial reporter facility name): osaka international medical & science center osaka police hospital; reported here as it exceeded the character limit for the designated field.Block h6: imdrf device code a0401 captures the event of a catheter guide break.Imdrf device code f2301 captures the event of an additional tool (forceps) to retrieve the broken guide catheter fragment.

• 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: 50147518
• Report Number: 3005099803-2026-03189
• Device Sequence Number: 13405999
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: (01)08714729856221(17)271017(10)39132096
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• 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,Followup
• Report Date (Section B): 09/29/2026

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: M00535060
• Device Catalogue Number: M00535060
• Device Lot Number: 0039132096
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2026
• 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 Sex: Unknown