85900PSTRH EAGLE EYE PLATINUM SHORT TIP CATHETER
Received Apr 29, 2026 · Event occurred Mar 26, 2026
Report 3032391-2026-00003 · MDR key 25034217
Device
Generic name
Eagle Eye Plat St Digital Ivus 5fx15
Manufacturer
Medline RenewalCatalog number
85900PSTRH
Lot number
467797
Product problems
- No Display/Image
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER,BLACKED OUT IMAGE ON THE CATHETER-THE SUBSEQUENT ONE DID NOT WORK AS WELL. THEY SAID THIS OCCURRED AFTER IT WAS WORKING AND PULLING IT OUT AND PLACING IT BACK INTO THE PATIENT. THERE ARE TWO DEVICES, AND ONE DISPLAYS IMAGE ONE DOES NOT AFTER WE REPLUGGED THEM IN THE LAB. AFTER THE SECOND FAILURE THEY SWITCHED TO FFR. THERE WERE 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 MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE CUSTOMER, THE PRODUCT BLACKED OUT IMAGE ON THE CATHETER-THE SUBSEQUENT ONE DID NOT WORK AS WELL. THEY SAID THIS OCCURRED AFTER IT WAS WORKING AND PULLING IT OUT AND PLACING IT BACK INTO THE PATIENT. THERE ARE TWO DEVICES, AND ONE DISPLAYS IMAGE ONE DOES NOT AFTER WE REPLUGGED THEM IN THE LAB. AFTER THE SECOND FAILURE THEY SWITCHED TO FFR.