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

Model Number	M001182910
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device removal difficulty occurred.The target lesion was located in the vessel in the liver.A 150/20 renegade hi flo and a.014/190cm gw transend periph was selected for use.During the procedure, the renegade and transcend devices were unable to advance through a 5f guide catheter at the proximal end, just beyond the hub.A new guide was attempted, but the same issue occurred with the first renegade and transcend.New renegade and transcend devices were then opened and advances to the tip of the 5f guide, the renegade would not advance out the tip of the guide.It was noted that there were grittiness and friction during insertion and removal.The procedure was completed with a non-boston device.There were no patient complications as a result of this event.

• 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: 24456304
• Report Number: 2124215-2026-10706
• Device Sequence Number: 13253974
• Product Code: KRA
• UDI-Device Identifier: 08714729280668
• UDI-Public: (01)08714729280668(17)280714(10)36977006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: M001182910
• Device Catalogue Number: M001182910
• Device Lot Number: 0036977006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 07/15/2025
• 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