MalfunctionOBJ
ACUNAV 8F
Received Jun 17, 2026 · Event occurred Jun 11, 2026
Report 3023245-2026-00043 · MDR key 25537132
Device
Generic name
Catheter, Ultrasound, Intravascular
Manufacturer
Siemens Medical Solutions Usa, Inc.Model number
10135936Product problems
- Connection Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE ACUNAV CATHETER COULD NOT BE RECOGNIZED BY THE ULTRASOUND MACHINE AFTER INSERTION INTO THE PATIENT'S BODY. REPLACING THE CATHETER DID NOT RESOLVE THE ISSUE AND THE EXAM WAS COMPLETED BY SWITCHING TO ANOTHER ULTRASOUND MACHINE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.
Additional Manufacturer Narrative
AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE # (B)(4).