MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RENEGADE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	29417
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that coating issue occurred.A 130/20/1tip renegade microcatheter was selected for use in the liver for a transcatheter arterial chemoembolization (tace) procedure.When the device was withdrawn, it was noted that the coating felt a little bit wrong.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that coating issue occurred.A 130/20/1tip renegade microcatheter was selected for use in the liver for a transcatheter arterial chemoembolization (tace) procedure.When the device was withdrawn, it was noted that the coating felt a little bit wrong.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that during preparation.A kink was observed on the device.When removed, there was a peeling section of the coating on the device.
Additional Manufacturer Narrative
Device evaluated by mfr: the renegade was returned for analysis.Microscopic examination revealed hydrophilic coating peeling located approximately 69.5 cm from the strain relief.No other issues were identified with the device.
Event or Problem Description
It was reported that coating issue occurred.A 130/20/1tip renegade microcatheter was selected for use in the liver for a transcatheter arterial chemoembolization (tace) procedure.When the device was withdrawn, it was noted that the coating felt a little bit wrong.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that during preparation.A kink was observed on the device.When removed, there was a peeling section of the coating on the device.

• Brand Name: RENEGADE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 21928575
• Report Number: 2124215-2025-24919
• Device Sequence Number: 9021807
• Product Code: KRA
• UDI-Device Identifier: 08714729235125
• UDI-Public: (01)08714729235125(17)261212(10)33051257
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K973645
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 29417
• Device Catalogue Number: 29417
• Device Lot Number: 0033051257
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 06/13/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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: 71 YR
• Patient Sex: Male