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

Model Number	M001182880
Medical Device Problem Codes	Difficult to Advance (2920); 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	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that coating issue occurred.Patient was presented with hemoptysis.A 135/10 renegade hi flo was selected for use in a pulmonary aorta.During procedure, difficulty in microcatheter delivery was noted.When removed, it was visually observed that the hydrophilic coating at the tip's front end had noticeably peeled off.When touched, the device felt obviously not smooth.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the renegade hi-flo was returned for analysis.Visual and microscope were performed.It revealed shaft kinks located approximately 121cm and 132cm from the strain relief.Peeling to shaft approximately 123cm from the strain relief.Device to device test performed with a 5french guide catheter failed.The microcatheter jammed at the shaft flake near the distal tip.No other issues were identified with the device.
Event or Problem Description
It was reported that coating issue occurred.Patient was presented with hemoptysis.A 135/10 renegade hi flo was selected for use in a pulmonary aorta.During procedure, difficulty in microcatheter delivery was noted.When removed, it was visually observed that the hydrophilic coating at the tip's front end had noticeably peeled off.When touched, the device felt obviously not smooth.The procedure was completed with another of same 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: 21829591
• Report Number: 2124215-2025-21564
• Device Sequence Number: 17199481
• Product Code: KRA
• UDI-Device Identifier: 08714729280637
• UDI-Public: (01)08714729280637(17)270706(10)34380212
• 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
• Report Date (Section B): 05/28/2025

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: M001182880
• Device Catalogue Number: M001182880
• Device Lot Number: 0034380212
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2024
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG