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

Model Number	29462
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire fractured internally.A renegade hi-flo fathom system was selected for use within the moderately tortuous right internal iliac - gluteus branch.During the procedure, approximately 3 cm of the distal segment of the guidewire fractured within the patient.The device deficiency was deemed non-consequential to the patient condition.There were no immediately reported patient complications.No further details were provided regarding the procedure outcome or patient status, despite request by boston scientific.
Additional Manufacturer Narrative
Corrected fields : h1 - type of reportable event.H6 - impact codes.Device analysis: the returned device consisted of renegade hi-flo with fathom guidewire inserted.Visual and microscopic examination revealed the microcatheter had multiple shaft kinks.Additionally, it was revealed that the guidewire had a bend located approximately 150.5 cm from the proximal end and a fracture located approximately 175 cm from the proximal end.
Event or Problem Description
It was reported that the guidewire fractured internally.A renegade hi-flo fathom system was selected for use within the moderately tortuous right internal iliac - gluteus branch.During the procedure, approximately 3 cm of the distal segment of the guidewire fractured within the patient.The device deficiency was deemed non-consequential to the patient condition.There were no immediately reported patient complications.No further details were provided regarding the procedure outcome or patient status, despite request by boston scientific.

• 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: 20669806
• Report Number: 2124215-2024-70175
• Device Sequence Number: 7304783
• Product Code: KRA
• UDI-Device Identifier: 08714729790884
• UDI-Public: 08714729790884
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0033603413
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown