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

Model Number	29460
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that tip fracture occurred.The target lesion was located in the right radial artery.A 135/10 renegade hi-flo kit with fathom guidewire were selected for use.During the procedure, the lesion was embolized with a microcatheter, and the front part of the guidewire equipped with the microcatheter was shaped before superselective intubation of the left uterine artery.However, it was noted that the front part of the guidewire was fractured, and the tip was not completely separated.The device was replaced, and the procedure was completed with a different device.No patient complications were reported, and the patient recovered well and has been discharged from the hospital.

• 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: 18303978
• Report Number: 2124215-2023-67776
• Device Sequence Number: 12329021
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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: 10/01/2024
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0030461390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: 42 YR
• Patient Sex: Female