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

Model Number	M001183020
Medical Device Problem Codes	Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microcatheter rupture occurred.A 135/10 renegade hi flo was selected for liver cancer rupture embolization.During the procedure, the microcatheter ruptured when it became twisted.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the renegade hi flo was returned for analysis.Visual examination revealed shaft fracture located approximately 2cm and 13cm from the hub.A stretched shaft sections located approximately 13cm to 17.5cm from the hub.Stretched section located approximately 2cm to 9cm from the hub.Microscopic examination revealed multiple shaft kinks.No other issues were identified with the device.
Event or Problem Description
It was reported that microcatheter ruptured occurred.A 135/10 renegade hi flo was selected for liver cancer rupture embolization.During the procedure, the microcatheter ruptured when it became twisted.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22555457
• Report Number: 2124215-2025-47266
• Device Sequence Number: 9700639
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: (01)08714729280774(17)260822(10)34691868
• 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): 09/08/2025

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: 08/22/2026
• Device Model Number: M001183020
• Device Catalogue Number: M001183020
• Device Lot Number: 0034691868
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 60 KG