MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC NUVISION NAV ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	FG12081
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter entered the body, worked for the majority of the case.Then it froze and would not unfreeze.Md requested different brand ice catheter.Problem solved.

• Brand Name: NUVISION NAV ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER, INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 23802470
• Report Number: 23802470
• Device Sequence Number: 18489081
• Product Code: OBJ
• UDI-Device Identifier: 10846835026559
• UDI-Public: (01)10846835026559
• 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): 11/20/2025
• Report Date (Section F): 11/20/2025

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: FG12081
• Device Catalogue Number: FG12081
• Device Lot Number: 31694517L
• 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: 12/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Date Report Sent to FDA: 11/20/2025