STEREOTAXIS
Received Jun 7, 2023 · Event occurred May 12, 2023
Report 17078300 · MDR key 17078300
Device
Generic name
Catheter Remote Control System
Manufacturer
Stereotaxis, IncProduct problems
- Inadequate User Interface
Patient
26645 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IN ANY STEREOTAXIS CASE, THE SMARTABLATE PUMP FOR CARTO WILL FUNCTION FINE FOR A FEW SECONDS UNTIL IT EVENTUALLY ALARMS FOR BUBBLES/MICROBUBBLES. BUT THERE ARE NO BUBBLES! WE HAVE TRIED SETTING IT ON DIFFERENT SURFACES, ALCOHOL SWABBING THE BUBBLE SENSOR, AND SWITCHING OUT PUMPS. SOMETHING ABOUT STEREOTAXIS CAUSES SOME SORT OF INTERFERENCE WITH THE SENSOR. WE END UP JUST NEEDING TO DO SMALL LESIONS FOR ABLATIONS OR SOMETIMES END UP NEEDING TO COMPLETELY SWITCH TACTICS TO DO MANUAL ABLATION AND SCRAP THE STEREOTAXIS ALTOGETHER.
Description of Event or Problem
IN ANY STEREOTAXIS CASE, THE SMARTABLATE PUMP FOR CARTO WILL FUNCTION FINE FOR A FEW SECONDS UNTIL IT EVENTUALLY ALARMS FOR BUBBLES/MICROBUBBLES. BUT THERE ARE NO BUBBLES! WE HAVE TRIED SETTING IT ON DIFFERENT SURFACES, ALCOHOL SWABBING THE BUBBLE SENSOR, AND SWITCHING OUT PUMPS. SOMETHING ABOUT STEREOTAXIS CAUSES SOME SORT OF INTERFERENCE WITH THE SENSOR. WE END UP JUST NEEDING TO DO SMALL LESIONS FOR ABLATIONS OR SOMETIMES END UP NEEDING TO COMPLETELY SWITCH TACTICS TO DO MANUAL ABLATION AND SCRAP THE STEREOTAXIS ALTOGETHER. STEREOTAXIS WAS CONTACTED. THEY RECOMMENDED TAPING THE TUBING TO THE SIDE OF THE SMART ABLATE PUMP DURING STEREOTAXIS CASES, IN ORDER TO SECURE THE TUBING AND REDUCE VIBRATIONS DURING ABLATION THAT SEEM TO THEN CAUSE THE PUMP TO ALERT.