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

Model Number	10135936
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unable to detect ice catheter on monitor/no image.After troubleshooting machine, existing ice catheter removed from the body, and new catheter placed with no issue.

• Brand Name: ACUNAV 8F ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 22010 se 51 street; issaquah WA 98029
• MDR Report Key: 19837646
• Report Number: 19837646
• Device Sequence Number: 20787470
• Product Code: OBJ
• UDI-Device Identifier: 04056869001029
• UDI-Public: (01)04056869001029
• 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): 06/26/2024
• Report Date (Section F): 06/26/2024

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: 10135936
• 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: 07/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White
• Date Report Sent to FDA: 06/26/2024