CATHETER, ULTRASOUND, INTRAVASCULAR
Received Jun 30, 2026 · Event occurred Jun 9, 2026
Report 3023245-2026-00045 · MDR key 25670806
Device
Generic name
Catheter, Ultrasound, Intravascular
Manufacturer
Siemens Medical Solutions Usa Inc.Model number
08255790Product problems
- Incomplete or Inadequate Connection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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).
Description of Event or Problem
IT WAS REPORTED THAT UPON CONNECTION OF THE ACUNAV CATHETER, THE ACUNAV CATHETER WAS UNABLE TO BE SELECTED ON THE ULTRASOUND MACHINE. THE ACUNAV CATHETER WAS REPLACED WITHOUT RESOLUTION. THE CALLER STATED THAT THE CARTO 3 SYSTEM WAS NOT IN USE AT THE TIME. THE ULTRASOUND MACHINE WAS REPLACED, AND THE ACUNAV CATHETER WAS REPLACED WITH A SOUNDSTAR CATHETER. THE CALLER STATED THAT THE CARTO 3 SYSTEM WAS POWERED ON IN ORDER TO USE THE SOUNDSTAR CATHETER. THE CALLER STATED THAT THERE WERE NO ISSUES WITH THE SOUNDSTAR CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE CALLER STATED THAT THE ACUNAV CATHETERS WERE BRAND NEW. THE PATIENT WAS SEDATED AT THE TIME; HOWEVER, NO PATIENT IMPACT WAS REPORTED.