EAGLE EYE PLAT ST DIGITAL IVUS 5FX150CM
Received Jan 20, 2025 · Event occurred Dec 20, 2024
Report 3032391-2025-00001 · MDR key 21193464
Device
Generic name
Eagle Eye Plat St Digital Ivus 5fx150cm
Manufacturer
Medline RenewalCatalog number
85900PSTRH
Lot number
300005383911-272429
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON (B)(6) 2024 DURING THE MIDDLE OF A STANDARD PROCEDURE, THE DEVICE GOT STUCK ON A WIRE AND THEY HAD DIFFICULTY REMOVING IT OUT OF THE BODY. AFTER THE ISSUE, THEY USED A DIFFERENT DEVICE AND STARTED OVER. THERE WAS A TIME DELAY TO THE PROCEDURE AS WELL. THE FACILITY STATED THERE WAS NO IMPACT TO THE PATIENT AND NO IMPACT TO THE PROCEDURE. A DEVICE IS AVAILABLE FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. 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 FACILITY ON (B)(6) 2024 DURING THE MIDDLE OF A STANDARD PROCEDURE, THE DEVICE GOT STUCK ON A WIRE AND THEY HAD DIFFICULTY REMOVING IT OUT OF THE BODY.