MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE? HI-FLO?; CATHETER, CONTINUOUS FLUSH

Model Number	M001182900
Medical Device Problem Codes	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	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter and guidewire became entrapped.A renegade? hi-flo? microcatheter and a 0.016" fathom? guidewire were selected for use in a procedure.It was noted that the guidewire became stuck in the microcatheter.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the microcatheter and guidewire became entrapped.A renegade? hi-flo? microcatheter and a 0.016" fathom? guidewire were selected for use in a procedure.It was noted that the guidewire became stuck in the microcatheter.There were no patient complications as a result of this event.It was further reported that the microcatheter did not track over the guidewire correctly.
Additional Manufacturer Narrative
Device evaluated by mfr: the renegade hi-flo device was returned to our post market quality assurance laboratory.The returned device consists of a renegade hi-flo with a 0.016" guidewire inserted.Visual examination revealed a microcatheter stretched shaft section located approximately 8cm to 22.5cm from the strain relief.Functional test failed due to microcatheter stretched and entrapment over wire.This concludes the product analysis.
Event or Problem Description
It was reported that the microcatheter and guidewire became entrapped.A renegade? hi-flo? microcatheter and a 0.016" fathom? guidewire were selected for use in a procedure.It was noted that the guidewire became stuck in the microcatheter.There were no patient complications as a result of this event.It was further reported that the microcatheter did not track over the guidewire correctly.

• Brand Name: RENEGADE? HI-FLO?
• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23617022
• Report Number: 2124215-2025-83117
• Device Sequence Number: 21074921
• Product Code: KRA
• UDI-Device Identifier: 08714729280651
• UDI-Public: (01)08714729280651(17)270920(10)34893624
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/14/2026

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: M001182900
• Device Catalogue Number: M001182900
• Device Lot Number: 0034893624
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 12/18/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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