FDA Adverse Event
Injury
Summary report: N
TVC INSIGHT CATHETER
MDR report key: 7023059
·
Received November 10, 2017
Report
- Report Number
- 3004722468-2017-00003
- Event Type
- Injury
- Date Received
- November 10, 2017
- Date of Event
- October 6, 2017
- Report Date
- November 10, 2017
- Manufacturer
- INFRAREDX, INC.
- Product Code
- OGZ
- UDI-DI
- 00857595006203
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PERCUTANEOUS CORONARY INTERVENTION OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. THROMBUS WAS FORMED IN THE LAD WHILE ATTEMPTING TO CROSS A LESION WITH THE NIRS-IVUS CATHETER. THE CATHETER WAS REMOVED AND THE THROMBUS WAS ASPIRATED WITH AN ASPIRATION CATHETER TO RESTORE BLOOD FLOW. NO FURTHER ATTEMPT WAS MADE TO USE THE NIRS-IVUS CATHETER FOLLOWING ASPIRATION. OPERATOR REPORTED FEELING RESISTANCE WHILE ATTEMPTING TO CROSS THE LESION THROUGH THE TORTUOUS VESSEL, POSSIBLY HARMING THE INTIMA AND CAUSING A THROMBUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798250 | TVC INSIGHT CATHETER | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER | OGZ | INFRAREDX, INC. | TVC-C195-20 | G37614 | 00857595006203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |