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

Model Number	M001182880
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that shaft fracture occurred.The target lesion was located in the pulmonary aorta.A 135/10 renegade hi flo was selected for use.During the procedure, it was difficult to advance the microcatheter in the catheter.A visual inspection shows that the front end of the microcatheter was obviously uneven and the rear end of the microcatheter was fractured during advancing.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Device evaluated by mfr: the renegade hi-flo was returned for analysis.Microscopic examination revealed shaft kink located approximately 25cm from the strain relief.Shaft flattened section located 131.5cm - 134cm from the strain relief.Device to device test failed the devices are stuck together.X-ray imaging revealed no internal damage.No other issues were identified with the device.
Event or Problem Description
It was reported that shaft fracture occurred.The target lesion was located in the pulmonary aorta.A 135/10 renegade hi flo was used for treatment.During the procedure, it was difficult to advance the microcatheter in the catheter.A visual inspection shows that the front end of the microcatheter was obviously uneven and the rear end of the microcatheter was fractured during advancing.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.

• Brand Name: RENEGADE? HI-FLO?
• 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: 21762817
• Report Number: 2124215-2025-20405
• Device Sequence Number: 15569134
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: (01)08714729280637(17)270304(10)33556593
• 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): 05/21/2025

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 Model Number: M001182880
• Device Catalogue Number: M001182880
• Device Lot Number: 0033556593
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 55 KG