VEIN360 LLC
Received Jun 24, 2026 · Event occurred May 28, 2026
Report 3032391-2026-00050 · MDR key 25612499
Device
Generic name
Eagle Eye Plat St Digital
Manufacturer
Medline RenewalCatalog number
85900PSTRH
Lot number
555556
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED BY THE CUSTOMER "PRIOR TO THE CASE THE GUIDE WIRE BROKE, AND THEY MOVED ON TO USE A DIFFERENT PRODUCT THAT WORKED. HAPPENED BEFORE THE PROCEDURE STARTED." 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.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER "PRIOR TO THE CASE THE GUIDE WIRE BROKE, AND THEY MOVED ON TO USE A DIFFERENT PRODUCT THAT WORKED. HAPPENED BEFORE THE PROCEDURE STARTED."