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

Model Number	29460
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter fractured.A 105/20 renegade hi-flo kit was selected for use in an angiography of a bleeding patient.During the procedure, it was noted that the catheter broke, but no part of the device was left in the patient.The renegade was pulled out and exchanged for another renegade.No patient complications were reported.
Event or Problem Description
It was reported that the catheter fractured.A 105/20 renegade hi-flo kit was selected for use in an angiography of a bleeding patient.During the procedure, it was noted that the catheter broke, but no part of the device was left in the patient.The renegade was pulled out and exchanged for another renegade.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: a renegade hi-flo microcatheter was returned for analysis.The device was visually and microscopically inspected for damage.The renegade device showed a fracture located 5.3cm from the hub.Multiple bends and kinks were also confirmed throughout the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

• 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: 17720876
• Report Number: 2124215-2023-49014
• Device Sequence Number: 20638013
• Product Code: KRA
• UDI-Device Identifier: 08714729280743
• UDI-Public: 08714729280743
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/08/2023

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: 06/12/2024
• Device Model Number: 29460
• Device Catalogue Number: 29460
• Device Lot Number: 0029755183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown