G30-01 VIS-RX MICRO-IMAGING CATHETER

Description of Event or Problem

BOTH DOCTORS (B)(6) AT (B)(6) SAID THAT THEY ARE CONCERNED ABOUT THE ACCURACY OF THE LENGTH OF OUR SYSTEM. DR (B)(6) SAID THAT "THEY (THE GROUP) ARE ALL TALKING ABOUT IT, AND THEY DON'T BELIEVE IT." WHEN I DID A CASE WITH DR (B)(6) HE PLACED A 23 MM ABBOTT STENT, AND WHEN I MEASURED IT, THE SYSTEM MEASURED 27 MM. SO I WENT BACK AND LOOKED AT DOCTOR (B)(6) CASE FROM THE DAY PRIOR, AND THAT WAS A 26 MM BIOTRONIC STENT, AND IT MEASURED 26 MM EXACTLY. (I DID NOT GET THE OPPORTUNITY TO SHARE THIS WITH THE PHYSICIANS). I DID DOWNLOAD BOTH CASES, TRIED TO UPLOAD, BUT INTERNET WAS POOR, SO UNABLE TO, WILL RE-TRY WHEN I RETURN HOME ON (B)(6) 2023.

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 STENT LENGTH FOR TREATMENT.