COMET II
Received Oct 15, 2025 · Event occurred Sep 23, 2025
Report 2124215-2025-72496 · MDR key 23304702
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Boston Scientific CorporationModel number
2404-02Catalog number
2404-02
Lot number
0035907115
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
78 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THAT THIS DEVICE MET MANUFACTURING SPECIFICATION PRIOR TO DISTRIBUTION AND THERE NO MANUFACTURING DEVIATIONS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. INVESTIGATION CONCLUSION: THIS INVESTIGATION HAS BEEN ASSIGNED THE CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE FOLLOWING A REVIEW OF THE REPORTED EVENT DETAILS, AVAILABLE INFORMATION, AND PRODUCT RECORD REVIEW. IT IS LIKELY THAT THE ISSUE COULD BE RELATED TO OPERATIONAL FACTORS SUCH AS HANDLING, TECHNIQUE, AMONG OTHERS THAT CAUSED THE REPORTED EVENT, FURTHERMORE, BATCH RECORD REVIEW CONCLUDED THAT NO MANUFACTURING DEVIATIONS WERE IDENTIFIED DURING THE MANUFACTURING PROCESS.
Description of Event or Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A COMET II GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN UPON INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.
Additional Manufacturer Narrative
GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A COMET II GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS IN GOOD CONDITION POST PROCEDURE.