MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 10F ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	08255790
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Acunav 10fr was inserted and returned blurry image.Device was removed and replaced with new acunav 10fr and procedure continued as planned with no harm noted to patient.

• Brand Name: ACUNAV 10F ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 400 west morgan road; suite 100; ann arbor MI 48108
• MDR Report Key: 20782329
• Report Number: 20782329
• Device Sequence Number: 17394779
• Product Code: OBJ
• UDI-Device Identifier: 04056869001012
• UDI-Public: (01)04056869001012
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/02/2024
• Report Date (Section F): 09/02/2024

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: 08255790
• Device Catalogue Number: 08255790
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• 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: 81 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/02/2024