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

Model Number	M001183030
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	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the hepatic artery.A 135/20 renegade hi flo catheter-infusion was selected for use in a transcatheter arterial chemoembolization to treat liver cancer.During preparation, the tip of the catheter was completely separated.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the hepatic artery.A 135/20 renegade hi flo catheter-infusion was selected for use in a transcatheter arterial chemoembolization to treat liver cancer.During preparation, the tip of the catheter was completely separated.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).Investigation results: device evaluated by mfr: the renegade hi flo device was returned to our post market quality assurance laboratory.Visual examination revealed multiple shaft kinks and an outer shaft liner fracture located approximately 2cm from the strain relief while the inner lumen stretched from the outer liner shaft fracture to approximately 10cm from the strain relief.The guidewire revealed no damage.This concludes the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the renegade hi flo device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: boston scientific concludes the most probable root cause as cause linked to device but unable to trace more specifically, due to the reported information does not clearly indicate a cause of the reported issue.

• 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: 24177623
• Report Number: 2124215-2026-04408
• Device Sequence Number: 10016330
• Product Code: KRA
• UDI-Device Identifier: 08714729280781
• UDI-Public: (01)08714729280781(17)270715(10)36969279
• 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): 03/20/2026

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: M001183030
• Device Catalogue Number: M001183030
• Device Lot Number: 0036969279
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG