PRESSUREWIRE¿
Received Mar 23, 2026 · Event occurred Sep 1, 2025
Report 2024168-2026-01167 · MDR key 24666172
Device
Generic name
Transducer, Pressure, Catheter Tip
Manufacturer
Lightlab Imaging, Inc.Model number
C12059Catalog number
C12059
Lot number
31002G1
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Improper or Incorrect Procedure or Method
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN AN UNSPECIFIED ARTERY. THE PRESSUREWIRE X WIRELESS GUIDEWIRE DID NOT CONNECT WITH THE PA (AORTIC PRESSURE) FAILING TO EQUALIZE. ANOTHER PRESSUREWIRE X WIRELESS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. HOWEVER, THE DEVICE WAS NOTED TO BE EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
B3 - DATE OF EVENT/PROCEDURE ESTIMATED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.