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

Model Number	M001183020
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.It was reported that the patient underwent hepatic artery catheterization for perfusion chemotherapy.A 135/10 renegade hi flo kit was selected for use.During preparation for the procedure, the package was opened, and the catheter was flushed, after which it was noted that the tip was detached from the microcatheter body, and the inner braided wire was exposed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A4 - weight: 67.3 kg.
Event or Problem Description
It was reported that tip detachment occurred.It was reported that the patient underwent hepatic artery catheterization for perfusion chemotherapy.A 135/10 renegade hi flo kit was selected for use.During preparation for the procedure, the package was opened, and the catheter was flushed, after which it was noted that the tip was detached from the microcatheter body, and the inner braided wire was exposed.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A4 - weight: 67.3 kg.Device evaluated by mfr: the renegade hi flo was returned for analysis.Visual examination revealed shaft fracture located at the strain relief.Shaft stretched approximately 3cm from the strain relief.No other issues were identified with the device.

• Brand Name: RENEGADE? HI-FLO? KIT
• 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: 22341540
• Report Number: 2124215-2025-40391
• Device Sequence Number: 9126328
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: (01)08714729280774(17)260619(10)34272048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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 Expiration Date: 06/19/2026
• Device Model Number: M001183020
• Device Catalogue Number: M001183020
• Device Lot Number: 0034272048
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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 Age: 59 YR
• Patient Sex: Male