COMET II
Received Oct 16, 2025 · Event occurred Jul 14, 2025
Report 2124215-2025-71978 · MDR key 23310865
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Boston Scientific CorporationModel number
2404-02Catalog number
2404-02
Lot number
0036026328
Product problems
- Communication or Transmission Problem
- Adverse Event Without Identified Device or Use Problem
- Communication or Transmission Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINT DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS. INSPECTION OF THE DEVICE REVEALED THAT THERE WERE NUMEROUS BENDS AND KINKS THROUGHOUT THE BODY FROM DISTAL TO PROXIMAL, ADDITIONALLY THE WIRE RETURNED DETACHED FROM THE BODY AT 39 CM FROM DISTAL TO PROXIMAL. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS.
Description of Event or Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19SEP2025. IT WAS REPORTED THAT THERE WAS NO IMAGE. A COMET II PRESSURE GUIDEWIRE WAS SELECTED FOR USE. IT WAS REPORTED THAT THERE WAS NO IMAGE. HOWEVER, DEVICE ANALYSIS REVEALED THAT A PINHOLE WAS NOTED ON THE OUTER AT 5.2CM FROM THE TIP.