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

Model Number	M001183020
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the device was difficult to remove.The target lesion was located in the liver.A 135/10 renegade hi flo kit was selected for use.However, during the procedure, the microcatheter could not be used normally and was difficult to remove from the hepatic duct.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Event or Problem Description
It was reported that the device was difficult to remove.The target lesion was located in the liver.A 135/10 renegade hi flo kit was selected for use.However, during the procedure, the microcatheter could not be used normally and was difficult to remove from the hepatic duct.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the microcatheter got stuck by the angiographic catheter and could not be pulled out.The device was removed together with the angiographic catheter.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).H6: evaluation conclusion codes: updated.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24015177
• Report Number: 2124215-2026-01435
• Device Sequence Number: 18426035
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: (01)08714729280774(17)270629(10)36863870
• 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): 02/06/2026

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: M001183020
• Device Catalogue Number: M001183020
• Device Lot Number: 0036863870
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 06/29/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 55 KG