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

Model Number	M001184550
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); 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	09/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported detachment occurred.The target lesion was located in the peripheral artery.A renegade hi-flo fathom system was selected for use.During preparation, the catheter appeared frayed at the tip upon opening of the package.The procedure was completed with alternate device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported detachment occurred.The stenosed target lesion was located in the peripheral artery.A 16 180cm renhf 135cm 20 preload fathom was selected for use.During the preparation, the catheter appeared frayed at the tip upon opening of the package.The procedure was completed with alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the renegade hi flo microcatheter was returned to our post market quality assurance laboratory.During visual inspection it was found that the catheter's outer shaft was separated 3cm from the strain relief.Multiple kinks were also found on the catheter.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint.

• 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: 23381328
• Report Number: 2124215-2025-74131
• Device Sequence Number: 8790636
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: (01)08714729790860(17)280325(10)36162013
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: M001184550
• Device Catalogue Number: M001184550
• Device Lot Number: 0036162013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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 Sex: Unknown