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

Model Number	M001184540
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that removal difficulty occurred, the target lesion was located in the vessel of the liver.A renegade hi-flo fathom system was selected for use in the liver digital subtraction angiography intervention.During introduction, there was a problem with the guide wire, and it could not be drawn out.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 zip/post code added.E1: initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that removal difficulty occurred, the target lesion was located in the vessel of the liver.A renegade hi-flo fathom system was selected for use in the liver digital subtraction angiography intervention.During introduction, there was a problem with the guide wire, and it could not be drawn out.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).Device evaluated by mfr: the renegade hi flo was returned for analysis.During visual inspection it was found that the catheters outer shaft was separated 1cm-44cm from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint.
Event or Problem Description
It was reported that removal difficulty occurred, the target lesion was located in the vessel of the liver.A renegade hi-flo fathom system was selected for use in the liver digital subtraction angiography intervention.During introduction, there was a problem with the guide wire, and it could not be drawn out.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 23324385
• Report Number: 2124215-2025-73380
• Device Sequence Number: 10616207
• Product Code: KRA
• UDI-Device Identifier: 08714729790853
• UDI-Public: (01)08714729790853(17)280127(10)35722227
• 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): 12/19/2025

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: M001184540
• Device Catalogue Number: M001184540
• Device Lot Number: 0035722227
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/04/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/18/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 70 KG