MalfunctionDXO
COMET II
Received Jan 15, 2026 · Event occurred Dec 24, 2025
Report 2124215-2026-02857 · MDR key 24084751
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Boston Scientific CorporationModel number
2404-03Catalog number
2404-03
Lot number
0036261435
Product problems
- Difficult to Remove
- Deformation Due to Compressive Stress
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR CORONARY ANGIOGRAM. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN REMOVING THE DEVICE. THE DEVICE WAS ABLE TO BE REMOVED NORMALLY, AND AFTER REMOVAL IT WAS NOTICED THAT THE TIP WAS KINKED AT ABOUT 1CM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.