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

Model Number	M001183020
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coating issue on the catheter occurred.A 135/10 renegade hi flo was selected for use in a transcatheter arterial chemoembolization (tace).Upon unpacking, it was discovered that two sections of the catheter lacked coating and could not be used.The device was not introduced into the patient's body.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a coating issue on the catheter occurred.A 135/10 renegade hi flo was selected for use in a transcatheter arterial chemoembolization (tace).Upon unpacking, it was discovered that two sections of the catheter lacked coating and could not be used.The device was not introduced into the patient's body.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(4).Device evaluated by mfr: the renegade hi-flo device was returned for evaluation.Microscopic examination revealed 2 outer liner fractures with a stretched inner braided lumen.From proximal end the first stretched section is located approximately 3cm to 7cm while second stretched section is located approximately 35.5cm to 41cm from the strain relief.No other issues were identified during the product analysis.

• 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: 23534444
• Report Number: 2124215-2025-81550
• Device Sequence Number: 9065544
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: (01)08714729280774(17)270528(10)36625339
• 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): 02/17/2026

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: 0036625339
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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