FDA Adverse Event
Malfunction
Summary report: N
G10-01 GENTUITY HF-OCT IMAGING SYSTEM
MDR report key: 25221416
·
Received May 19, 2026
Report
- Report Number
- 3011578544-2026-00004
- Event Type
- Malfunction
- Date Received
- May 19, 2026
- Date of Event
- February 7, 2024
- Report Date
- February 8, 2024
- Manufacturer
- GENTUITY, LLC
- Product Code
- NQQ
- PMA / PMN Number
- K230620
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
POST-STENT IMAGING SHOWED A MEASURED LENGTH SHORTER THAN EXPECTED. REVIEW OF LOGS AND IMAGES CONFIRMED THE MANUALLY ADJUSTED STENT LENGTH MATCHED THE IMPLANTED 3.0 × 38 MM STENT. THE CATHETER PERFORMED NORMALLY. THE COMPLAINT COULD NOT BE CONFIRMED.
Description of Event or Problem · 0
NMC COMPLAINT (B)(4). DR. (B)(6) CASE. 3.0 X 38MM STENT PLACED IN OM2. POST STENT PULLBACK IMAGES DISPLAYED VIA STENT X SOFTWARE AS A LENGTH OF 23MM. I MANUALLY ADJUSTED THE LENGTH TO THE PROXIMAL AND DISTAL STENT EDGES. ADJUSTED LENGTH WAS APPROXIMATELY 30MM. LOGS AND IMAGES WERE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7946 | G10-01 GENTUITY HF-OCT IMAGING SYSTEM | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY | NQQ | GENTUITY, LLC | G10-01 | 23K0201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |