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

Model Number	M001184570
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the blue coating outside the guidewire was fractured.The target lesion was located in the liver.A 180cm renhf 150cm 20 preload renegade hi-flo fathom 16 system was selected for percutaneous selective hepatic arteriography, local chemotherapy and arterial embolization.During the procedure, when the package was opened and handed the device to the physician after soaking it in normal saline, the physician slowly pulled out the guidewire and noted that the blue coating outside the guidewire was fractured.The procedure was completed with another of same device.There were no patient complications as result of the event.
Event or Problem Description
It was reported that the blue coating outside the guidewire was fractured.The target lesion was located in the liver.A 180cm renhf 150cm 20 preload renegade hi-flo fathom 16 system was selected for percutaneous selective hepatic arteriography, local chemotherapy and arterial embolization.During the procedure, when the package was opened and handed the device to the physician after soaking it in normal saline, the physician slowly pulled out the guidewire and noted that the blue coating outside the guidewire was fractured.The procedure was completed with another of same device.There were no patient complications as result of the event.It was further reported that the fracture occurred on the coating of the catheter.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1: initial reporter phone: (b)(6).H6: evaluation conclusion codes: updated.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the renegade hi-flo device was returned for evaluation.The device was examined visually to reveal multiple shaft kinks.There is a stretched section located approximately 10cm to 16.5cm from the strain relief.No other issues were identified with the device.
Event or Problem Description
It was reported that the blue coating outside the guidewire was fractured.The target lesion was located in the liver.A 180cm renhf 150cm 20 preload renegade hi-flo fathom 16 system was selected for percutaneous selective hepatic arteriography, local chemotherapy and arterial embolization.During the procedure, when the package was opened and handed the device to the physician after soaking it in normal saline, the physician slowly pulled out the guidewire and noted that the blue coating outside the guidewire was fractured.The procedure was completed with another of same device.There were no patient complications as result of the event.It was further reported that the fracture occurred on the coating of the catheter.

• Brand Name: RENEGADE? HI-FLO? FATHOM? SYSTEM
• 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: 23291700
• Report Number: 2124215-2025-72268
• Device Sequence Number: 9926512
• Product Code: KRA
• UDI-Device Identifier: 08714729790884
• UDI-Public: (01)08714729790884(17)271114(10)35281682
• 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,Followup
• Report Date (Section B): 01/15/2026

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: M001184570
• Device Catalogue Number: M001184570
• Device Lot Number: 0035281682
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 12/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 62 KG