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

Model Number	M001182900
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.The 20% stenosed target lesion was located in the mildly tortuous and mildly calcified splenic artery.A 150/10 renegade hi flo and 165cm transend 18 guidewire were selected for embolization.The devices were prepared according to the instructions for use (ifu).However, during advancement, it was noted that the devices became stuck with the 0.038 non-boston scientific angiographic catheter and could not be pulled out.The devices were then pulled out directly and the procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).

• 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: 24384072
• Report Number: 2124215-2026-09225
• Device Sequence Number: 13417436
• Product Code: KRA
• UDI-Device Identifier: 08714729280651
• UDI-Public: (01)08714729280651(17)280228(10)35966153
• 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
• Report Date (Section B): 02/18/2026

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: M001182900
• Device Catalogue Number: M001182900
• Device Lot Number: 0035966153
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 02/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORDIS 5F ANGIOGRAPHIC CATHETER
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG