COMET II
Received Dec 5, 2025 · Event occurred Sep 1, 2025
Report 2124215-2025-88279 · MDR key 23733226
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Boston Scientific CorporationModel number
2404-02Catalog number
2404-02
Lot number
0036491329
Product problems
- Nonstandard Device
- Communication or Transmission Problem
- Nonstandard Device
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B3: DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE BSC, AWARE DATE AS THE EVENT DATE WAS NOT PROVIDED. DEVICE EVALUATED BY MFR. RETURNED PRODUCT CONSISTED OF AN FFR COMET PRESSURE WIRE WITH THE OCC CABLE AND TORQUE DEVICE. THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE RFID TAG ASSOCIATED WITH THIS DEVICE AND THE COEFFICIENT VALUES WERE CONFIRMED TO BE PROGRAMMED. A VISUAL INSPECTION OF THE DEVICE REVEALED THAT THERE WERE NUMEROUS BENDS THROUGHOUT THE BODY FROM DISTAL TO PROXIMAL. DEVICE-TO-DEVICE INTERACTION TEST REVEALED THAT THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE FFR LINK TO VERIFY THE SIGNAL STRENGTH. THERE WERE NO ISSUES IN CONNECTING TO THE FFR LINK. THE SIGNAL WAS PRESENT AND THE "SIGNAL STRENGTH" AND THE "ZEROED" LED LIGHTS SHOWED GREEN, AS DESIGNED. THE GREEN LED LIGHTS INDICATED THE WIRE WAS WORKING PROPERLY. THE DEVICE WAS THEN CONNECTED TO THE POLARIS (ILAB) TEST EQUIPMENT VIA BLUETOOTH SIGNAL. THE WIRE COMMUNICATED TO THE POLARIS SYSTEM AND ZEROED, AS DESIGNED. WITH THE WIRE INSERTED INTO THE TEST PRESSURE CHAMBER, THE WIRE TRANSFERRED A PRESSURE WAVEFORM TO THE POLARIS WHICH INDICATES A FUNCTIONING WIRE. FUNCTIONAL TEST REVEALED THAT THE SHROUD OF THE OCC CABLE WAS CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE MODULATION WAS CHECKED AND WAS 14.6 PERCENT. THE WIRE WAS INSERTED INTO THE PRESSURE CHAMBER. THE PRESSURE SENSOR FUNCTIONED AS DESIGNED. MICROSCOPE ANALYSIS REVEALED THE TIP WAS FOUND BENT AND STRETCHED, ADDITIONALLY, FOREIGN MATERIAL WAS OBSERVED ON THE WIRE.
Description of Event or Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10-NOV-2025. IT WAS REPORTED THAT NO PRESSURE SIGNAL OCCURRED. AN FG COMET II PRESSURE GUIDEWIRE WAS ADVANCED FOR TREATMENT BUT WHEN THE PRESSURE GUIDEWIRE THERE WAS CONNECTED, NO PRESSURE WAS MEASURED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT FOREIGN MATERIAL WAS OBSERVED ON THE WIRE.