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

Model Number	29460
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the vessel of the liver.A 135/10 renegade hi-flo kit was selected for transcatheter arterial chemoembolization (tace).However, after flushing with normal saline, it was noted that the surface of hydrophilic coting was rough, and the device could not cross the 5f imaging catheter to the lesion.The procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Inspection of the device revealed multiple slight shaft kinks; however, the kinks did not disrupt functional testing of the device.An.018-inch guidewire was received with the device and used to perform a guidewire insertion test.The device was flushed, and the guidewire passed with no issues.A test 5 fr guide catheter was used to perform an interaction test, and the device was flushed and passed through the device with no issues.No other issues were identified during the product analysis.Analysis of the device was unable to confirm the clinical observations.
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the vessel of the liver.A 135/10 renegade hi-flo kit was selected for transcatheter arterial chemoembolization (tace).However, after flushing with normal saline, it was noted that the surface of hydrophilic coting was rough, and the device could not cross the 5f imaging catheter to the lesion.The procedure was completed with another of the same device.No complications were reported and the patient was stable post-procedure.

• Brand Name: RENEGADE HI-FLO KIT
• 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: 19723914
• Report Number: 2124215-2024-41577
• Device Sequence Number: 20901603
• Product Code: KRA
• UDI-Device Identifier: 08714729280774
• UDI-Public: 08714729280774
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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 Expiration Date: 07/04/2025
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0032156693
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 65 KG