MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV G 8F ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	10135910
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Ice (intracardiac echocardiography) catheter inserted into body and image blurry, zero visualization.Different ice catheter opened, problem resolved.

• Brand Name: ACUNAV G 8F ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 5168 campus dr; plymouth meeting PA 19462
• MDR Report Key: 21303498
• Report Number: 21303498
• Device Sequence Number: 8169086
• Product Code: OBJ
• UDI-Device Identifier: 04056869001043
• UDI-Public: (01)04056869001043
• 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): 01/30/2025
• Report Date (Section F): 01/30/2025

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: 10135910
• Device Lot Number: G2205620
• 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: 02/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2025
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 01/30/2025