MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Renegade? HI-FLO? FATHOM? System; Catheter, Continuous Flush

Model Number	M001184540
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the left anterior descending vessel.A renegade hi-flo fathom system was selected for use during a transcatheter arterial chemoembolization (tace) procedure.During the procedure, the device was advanced; however, the guidewire and catheter became entrapped at a certain position and could neither be advanced nor withdrawn.Multiple attempts were made to resolve the issue, but the problem persisted.As a result, the guidewire and catheter were removed together with the angiography catheter.The procedure was completed with another of the same device.There were no patient complications as a result of this event.The patient remained stable following the procedure.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.If additional details become available, a supplemental report will be submitted.

• Brand Name: Renegade? HI-FLO? FATHOM? System
• Common Device Name: Catheter, Continuous Flush
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; business and technology park,; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 50818444
• Report Number: 2124215-2026-49930
• Device Sequence Number: 10648554
• Product Code: KRA
• UDI-Device Identifier: 08714729790853
• UDI-Public: (01)08714729790853(17)280709(10)36941693
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140329
• 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): 09/18/2026

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: M001184540
• Device Catalogue Number: M001184540
• Device Lot Number: 0036941693
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/10/2025
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 154 LB