GENTUITY HF-OCT IMAGING SYSTEM
Received May 27, 2026 · Event occurred Jul 9, 2024
Report 3011578544-2026-00027 · MDR key 25304521
Device
Generic name
System, Imaging, Optical Coherence
Manufacturer
Gentuity, LlcModel number
G10-01Catalog number
G10-01
Product problems
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
LITERATURE REVIEW DETERMINED THAT MOTION ARTIFACT CAN CAUSE MEASUREMENTS TO VARY BY A FEW MILLIMETERS. NO INDICATION OF A PRODUCT MALFUNCTION WAS FOUND. MOTION ARTIFACT COULD EXPLAIN THE DISCREPANCY BETWEEN THE MEASUREMENT BY THE GENTUITY SYSTEM AND THE DETERMINED LESION AND STENT LENGTH FOR TREATMENT.
Description of Event or Problem
WHILE DOING A CASE WITH DR (B)(6) YESTERDAY, HE WAS VERY UNHAPPY WITH THE LONGITUDINAL MEASUREMENTS. HE DID NOT BELIEVE THE PRE (WHICH I MEASURED AT 26 MM, AND HE THOUGHT IT REALLY SHOULD BE 28 OR EVEN 30MM). EVEN TO THE POINT THAT HE WANTED TO DISCUSS AFTER THE CASE. (IT WAS TOWARDS THE DISTAL END OF THE RUN). THE POST STENT MEASUREMENTS WERE OFF ALSO, WHICH I DID NOT BRING TO HIS ATTENTION. HE HAD PLACED A 28MM ABBOTT STENT, AND IT MEASURED 31MM. BOTH OCT RUNS AND LOGS WERE UPLOADED TO BOX.