VEIN360 REPROCESSED
Received Jun 24, 2026 · Event occurred May 27, 2026
Report 3032391-2026-00047 · MDR key 25612494
Device
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DEVICE DID NOT REGISTER WITH THE VOLCANO CONSOLE, CAUSING A FAULTY CAMERA ERROR TO APPEAR ON THE MACHINE. THIS HAPPENED PRIOR TO THE CASE BEGINNING AND PATIENT WAS NOT YET IN THE ROOM. NEW IVUS CATHETER WAS OPENED.
Additional Manufacturer Narrative
IT WAS REPORTED THAT DEVICE DID NOT REGISTER WITH THE VOLCANO CONSOLE, CAUSING A FAULTY CAMERA ERROR TO APPEAR ON THE MACHINE. THIS HAPPENED PRIOR TO THE CASE BEGINNING AND PATIENT WAS NOT YET IN THE ROOM. NEW IVUS CATHETER WAS OPENED. THERE ARE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.