MAUDE Adverse Event Report: SUREFIRE MEDICAL, INC. TRINAV INFUSION SYSTEM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	TNV-21120-35
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of right renal clear cell carcinoma.Procedure: angiogram/embolization of branches of the right renal artery.During an embolization, dr.Attempted to infusion ethanol through a trinav catheter and it "melted." trinav catheter removed intact, no known harm to patient.Discharged the next day.

• Brand Name: TRINAV INFUSION SYSTEM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): SUREFIRE MEDICAL, INC.; 6272 w 91st ave; westminster CO 80031
• MDR Report Key: 19040146
• Report Number: 19040146
• Device Sequence Number: 8471609
• Product Code: DQO
• UDI-Device Identifier: 00857136004217
• UDI-Public: (01)00857136004217(17)250831(10)230822C
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/12/2024
• Report Date (Section F): 03/13/2024

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
• Device Model Number: TNV-21120-35
• Device Catalogue Number: TNV-21120-35
• Device Lot Number: 230822C
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 04/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Female
• Date Report Sent to FDA: 03/13/2024