MAUDE Adverse Event Report: Siemens Medical Solutions USA, Inc. AcuNav 8F; Catheter, Ultrasound, Intravascular

Model Number	10135936
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction

• Brand Name: AcuNav 8F
• Common Device Name: Catheter, Ultrasound, Intravascular
• Manufacturer (Section D): Siemens Medical Solutions USA, Inc.; 22010 se 51st st; issaquah WA 98029
• Manufacturer (Section G): Siemens Medical Solutions USA, Inc.; 22010 se 51st st; issaquah WA 98029
• Manufacturer Contact: pragya jai kumar ; 22010 se 51st st; issaquah, WA 98029 ; +1(650)625-7209
• MDR Report Key: 50461945
• Report Number: 3023245-2026-00054
• Device Sequence Number: 15996369
• Product Code: OBJ
• UDI-Device Identifier: 04056869001029
• UDI-Public: 04056869001029
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 10135936
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown