G10-01 GENTUITY HF-OCT IMAGING SYSTEM
Report
- Report Number
- 3011578544-2026-00001
- Event Type
- Malfunction
- Date Received
- April 2, 2026
- Date of Event
- October 1, 2025
- Report Date
- March 10, 2026
- Manufacturer
- GENTUITY, LLC
- Product Code
- NQQ
- PMA / PMN Number
- K23O620
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
ON 3 NOV 2025, GENTUITY RECEIVED A COMPLAINT FROM ITS JAPANESE DISTRIBUTOR, (B)(4), REGARDING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PERFORMED BY DR. (B)(6). THE REPORTER STATED THAT A STENT WITH A LENGTH OF 38 MM WAS IMPLANTED INSTEAD OF A STENT WITH A CLINICALLY OPTIMAL LENGTH OF 25-26 MM, AND ATTRIBUTED THIS TO INACCURATE LESION LENGTH MEASUREMENT ASSOCIATED WITH A REPEATED FRAMES ISSUE AND CONCERNS ABOUT THE ACCURACY OF THE PULLBACK USING THE GENTUITY HF-OCT SYSTEM (VIS-RX CATHETER WITH HF-OCT CONSOLE). THE PHYSICIAN REPORTED THAT THE REPEATED FRAMES PHENOMENON RESULTED IN AN OVERESTIMATION OF LONGITUDINAL LESION LENGTH, WHICH INFLUENCED STENT LENGTH SELECTION IN A RECENT CLINICAL CASE. THE REPORTER EXPRESSED THAT, IN THEIR VIEW, THE SYSTEM FAILURE WARRANTED ACTION BY THE MANUFACTURER DUE TO THE IMPACT ON THE PROCEDURE. GENTUITY PROMPTLY CONDUCTED AN INTERNAL INVESTIGATION INTO THE ISSUE THROUGH THEIR DISTRIBUTOR (B)(4). REPEATING FRAMES DURING PULLBACK HAVE BEEN PREVIOUSLY IDENTIFIED AS A WELL-KNOWN BEHAVIOR OF ANY OCT SYSTEM INCLUDING THE GENTUITY HF OCT IMAGING SYSTEM. ACCORDING TO THE INTERNAL PRODUCT SPECIFICATION, THE VIS-RX CATHETER AND HF-OCT CONSOLE SYSTEM WERE VERIFIED TO PROVIDE ACCURATE LONGITUDINAL LENGTH MEASUREMENTS WITHIN THE CENTRAL 80% OF THE MEASURED LENGTH (I.E, THE CENTRAL 80 MM OF A 100 MM PULLBACK). AS PART OF THE INVESTIGATION, GOODMAN EVALUATED SYSTEM PERFORMANCE UNDER DIFFERENT PULLBACK CONDITIONS. THIS INVESTIGATION YIELDED THE FOLLOWING KEY TECHNICAL OBSERVATIONS: 1. WHEN PULLBACK SPEED WAS FASTER (E.G., 1 SECOND), THE LONGITUDINAL MEASUREMENT ERROR INCREASED. 2. WHEN PERFORMING A 100 MM PULLBACK WITH A 1 SECOND PULLBACK TIME, THE LENGTH OVER WHICH REPEATED FRAMES RANGED FROM 8.0 MM TO 9.2 MM IN THE DISTAL REGION. THE REPEATED FRAMES REMAINED OUTSIDE OF THE SPECIFIED CENTRAL 80 MM SEGMENT WHERE ACCURATE LONGITUDINAL LENGTH MEASUREMENTS WERE VERIFIED. BASED ON THE ANALYSIS OF THE REPORTED CASE, IT WAS DETERMINED THAT THE STARTING POINT OF THE LONGITUDINAL MEASUREMENT WAS NOT ADJUSTED BY THE USER TO EXCLUDE THE SEGMENT AFFECTED BY REPEATED FRAMES. FAILURE TO RESET THE MEASUREMENT START POINT TO A PORTION OF THE PULLBACK FREE OF REPEATED FRAMES CAN RESULT IN OVERESTIMATION OF LENGTH MEASUREMENTS OUTSIDE OF THE CENTRAL 80 MM SEGMENT. A REVIEW OF GENTUITY¿S COMPLAINT DATABASE WAS CONDUCTED FOR THE PERIOD SEPTEMBER 2022 THROUGH NOVEMBER 2025. DURING THIS TIME, APPROXIMATELY 5,169 CATHETERS WERE USED IN THE FIELD. FOURTEEN (14) COMPLAINTS RELATED TO REPEATING FRAMES WERE IDENTIFIED FROM SEPTEMBER 2022 TO NOVEMBER 2025. OF THESE, ONE (1) COMPLAINT RESULTED IN CONFIRMED IMPLANTATION OF A CLINICALLY SUB OPTIMAL STENT LENGTH. THIS COMPLAINT WAS THE ONLY REPORTED INCIDENT IN WHICH REPEATED FRAMES WERE ASSOCIATED WITH IMPLANTATION OF A CLINICALLY SUB-OPTIMAL STENT LENGTH. THIS CORRESPONDS TO AN ESTIMATED OCCURRENCE RATE OF APPROXIMATELY (B)(4) (1 OCCURRENCE IN 5169 CATHETERS USED). ADDITIONALLY, A BROADER REVIEW OF COMPLAINTS WAS PERFORMED TO IDENTIFY ANY OTHER REPORTS IN WHICH USERS EXPRESSED CONCERN THAT REPEATED FRAMES RESULTED IN INCORRECT STENT PLACEMENT. NO ADDITIONAL SUCH CASES WERE IDENTIFIED FROM ANY REGION, INCLUDING JAPAN, THE EUROPEAN UNION, AND THE UNITED STATES, DURING THE SAME TIME FRAME. FROM A CLINICAL STANDPOINT, LONGER STENTS MAY PROVIDE IMPROVED COVERAGE FOR LONGER LESIONS; HOWEVER, THEIR USE MUST BE BALANCED AGAINST PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PUBLISHED CLINICAL LITERATURE INDICATES THAT INCORRECT STENT DIAMETER (UNDER-SIZING) CAN BE ASSOCIATED WITH ADVERSE CARDIOVASCULAR OUTCOMES. IN CONTRAST, THE USE OF A LONGER STENT LENGTH, IN AND OF ITSELF, HAS NOT BEEN SHOWN TO SIGNIFICANTLY INCREASE MAJOR ADVERSE CARDIOVASCULAR EVENT RATES PROVIDED THAT DIAMETER SIZING IS APPROPRIATE AND IMPLANTATION TECHNIQUE IS ADEQUATE. CONSEQUENTLY, CLINICAL BEST PRACTICE EMPHASIZES CAREFUL SELECTION OF STENT DIAMETER, AND AVOIDANCE OF INACCURATE DIAMETER IMPLANTATION, AS A KEY STRATEGY TO MINIMIZE RISK. IN THE SUBJECT CASE, THE CONCERN WAS RELATED TO STENT LENGTH SELECTION, NOT STENT DIAMETER. FURTHERMORE, STENT IMPLANTATION DURING PCI PROCEDURES IS CONDUCTED UNDER ANGIOGRAPHIC GUIDANCE WITH THE HF-OCT CATHETER REMOVED FROM THE BODY AND THE HF-OCT SYSTEM NOT IN USE AT THAT POINT. RADIO-OPAQUE MARKERS ON THE STENT DELIVERY CATHETER CLEARLY INDICATE THE ACTUAL LENGTH OF THE DEVICE AND PROVIDE CLEAR VISUAL INDICATORS OF THE STENT LENGTH RELATIVE TO OTHER ANATOMIC LANDMARKS INCLUDING PREVIOUSLY DEPLOYED STENTS. THEREFORE, ANY POTENTIAL ISSUE WITH STENT LENGTH SELECTION IS IMMEDIATELY APPARENT UNDER ANGIOGRAPHY PRIOR TO STENT IMPLANTATION (INDEPENDENT OF THE HF-OCT MEASUREMENTS), WHICH SHOULD PROVIDE AMPLE OPPORTUNITY FOR A PHYSICIAN TO RETRACT THE STENT PRIOR TO DEPLOYMENT AND SELECT A MORE OPTIMAL STENT LENGTH. IN SUMMARY, THE INVESTIGATION CONFIRMED THAT REPEATED FRAMES CAN OCCUR AND THAT FAILURE TO ADJUST THE LENGTH MEASUREMENT STARTING POINT TO EXCLUDE THESE FRAMES CAN CONTRIBUTE TO OVERESTIMATION OF LESION LENGTH. THE EVENT REPRESENTS A RARE OCCURRENCE RELATIVE TO OVERALL DEVICE USAGE OVER THE PAST YEAR AND ALIGNS WITH AN EXISTING, PREVIOUSLY ASSESSED RISK (RC0225) THAT REMAINS WITHIN THE LOW RESIDUAL RISK CATEGORY. GENTUITY HAS TAKEN CORRECTIVE ACTION TO REINFORCE CORRECT USE OF LONGITUDINAL MEASUREMENTS AND MITIGATION OF REPEATED-FRAME RELATED ARTIFACTS.
A PHYSICIAN, DR. (B)(6), REPORTED AN ISSUE WITH THE GENTUITY HF-OCT IMAGING SYSTEM OPERATING WITH SOFTWARE VERSION 23.3.13 DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PULLBACK, THE OCT IMAGE REMAINED STATIONARY FOR APPROXIMATELY 9.9 MM AT THE BEGINNING (MOST DISTAL SEGMENT) OF THE 100 MM ACQUISITION. USING THE HF OCT IMAGING SYSTEM, THE PHYSICIAN SUBSEQUENTLY MEASURED THE LONGITUDINAL LENGTH OF A REGION OF INTEREST CONTAINING A CORONARY LESION THAT PARTIALLY INCORPORATED THE STATIONARY 9.9 MM SEGMENT. THIS LONGITUDINAL MEASUREMENT INDICATED A LESION LENGTH OF 34.2 MM. BASED ON THE SYSTEM REPORTED MEASUREMENT, THE OPERATOR SELECTED AND IMPLANTED A 38 MM STENT TO TREAT A LESION LOCATED BETWEEN PREEXISTING STENTS IN THE LCX (IDENTIFIED AS #11 AND #13). HOWEVER, AFTER STENT IMPLANTATION UNDER ANGIOGRAPHIC GUIDANCE, THE REPORTER INDICATED THAT HE BELIEVED A CLINICALLY OPTIMAL STENT LENGTH, ACCOUNTING FOR OVERLAP BETWEEN THE PRE-EXISTING STENTS, WOULD HAVE BEEN APPROXIMATELY 25¿26 MM RATHER THAN 38 MM. AS A RESULT, A LONGER STENT WAS DEPLOYED THAN WHAT WAS CLINICALLY OPTIMAL. THE REPORTER ATTRIBUTED THE LENGTH OVERESTIMATION TO A REPEATED FRAMES PHENOMENON FOR WHICH NO CORRECTIVE ALGORITHM WAS APPLIED IN SOFTWARE VERSION 23.3.13. THE COMPLAINANT FURTHER REQUESTED AN INVESTIGATION INTO THE ACCURACY OF MEASUREMENTS WITHIN THE CENTRAL (¿MIDDLE 80%¿) REGION OF THE OCT IMAGE AND WHETHER REPEATED FRAMES MAY HAVE AFFECTED THE MEASUREMENT INTEGRITY IN THAT PORTION OF THE DATASET. THE REPEATED FRAMES WERE FOUND TO BE OUTSIDE OF THE CENTRAL ¿MIDDLE 80%¿ REGION OF THE OCT IMAGE. THE HF-OCT IMAGING SYSTEM IS SPECIFIED TO PROVIDE ACCURATE LONGITUDINAL LENGTH MEASUREMENTS IN THE MIDDLE 80% REGION OF THE OCT IMAGE. PATIENT IMPACT: THE PATIENT RECEIVED A CORONARY STENT LONGER THAN WHAT WAS DEEMED TO BE CLINICALLY OPTIMAL. THE COMPLAINT INDICATED THAT THERE WAS NO PATIENT IMPACT. DEVICE INVOLVEMENT: GENTUITY HF OCT IMAGING SYSTEM, SOFTWARE VERSION 23.3.13. REPORTER ALLEGATION: INACCURATE LESION LENGTH MEASUREMENT DUE TO UNCORRECTED REPEATED FRAMES DURING PULLBACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823114 | G10-01 GENTUITY HF-OCT IMAGING SYSTEM | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) | NQQ | GENTUITY, LLC | G10-01 | 24B0104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |