MAUDE Adverse Event Report: NUVERA MEDICAL, INC. NUVISION ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	FG10593
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Error code " the probe may have a technical issue." please reconnect and reselect probe - no patient harm.

• Brand Name: NUVISION ICE CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): NUVERA MEDICAL, INC.; 140 knowles dr; los gatos CA 95032
• MDR Report Key: 20586646
• Report Number: 20586646
• Device Sequence Number: 12958745
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: (01)00860005688104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/16/2024
• Report Date (Section F): 10/16/2024

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 Model Number: FG10593
• Device Lot Number: 31310311LN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Date Report Sent to FDA: 10/16/2024