COMET II
Received Jan 14, 2026 · Event occurred Nov 6, 2025
Report 2124215-2026-02627 · MDR key 24073134
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Boston Scientific CorporationModel number
2404-03Catalog number
2404-03
Lot number
0036902802
Product problems
- Nonstandard Device
- Deformation Due to Compressive Stress
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17JAN2026. IT WAS REPORTED THAT WIRE WAS KINKED OR DEFORMED. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE WAS KINKED OR DEFORMED LESS THAN 3 CM FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE TIP WAS DETACHED FROM THE TIP WELD.
Additional Manufacturer Narrative
DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. A VISUAL INSPECTION OF THE DEVICE REVEALED THAT THERE WERE NUMEROUS KINKS THROUGHOUT THE BODY FROM DISTAL TO PROXIMAL, ADDITIONALLY THE TIP WAS FOUND BENT AND DETACHED FROM THE TIP WELD. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. E1-INITIAL REPORTER CITY: (B)(6).