COMET II
Received May 27, 2026 · Event occurred Mar 13, 2026
Report 2124215-2026-28481 · MDR key 25306011
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Boston Scientific CorporationModel number
2404-02Catalog number
2404-02
Lot number
0037889899
Product problems
- Reset Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PROCEDURE WAS CANCELLED. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. IT WAS NOTED THAT THE CONSOLE POWERS ON CORRECTLY WITH A GREEN POWER INDICATOR, HOWEVER WHEN A GUIDEWIRE WAS INSERTED A RED LIGHT WOULD APPEAR. TROUBLESHOOTING WAS ATTEMPTED BY SWITCHING THE DEVICE OFF AND ON. AFTER REINSERTION OF THE GUIDEWIRE, THE RED LIGHT REMAINS. A SECOND COMET II PRESSURE GUIDEWIRE WAS USED BUT THE SAME PROBLEM OCCURRED. DUE TO THIS ISSUE, THE PROCEDURE COULD NOT BE PERFORMED AND WAS RESCHEDULED.