FDA Adverse Event
Malfunction
Summary report: N
TVC INSIGHT XB¿
MDR report key: 8566721
·
Received April 30, 2019
Report
- Report Number
- 3004722468-2019-00001
- Event Type
- Malfunction
- Date Received
- April 30, 2019
- Date of Event
- April 3, 2019
- Report Date
- April 30, 2019
- Manufacturer
- INFRAREDX, INC.
- Product Code
- OBJ
- PMA / PMN Number
- K141682
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PERCUTANEOUS CORONARY INTERVENTION. DIAGNOSTIC IMAGING WITH A COMBINATION NEAR-INFRARED SPECTROSCOPY (NIRS) AND INTRAVASCULAR ULTRASOUND (IVUS) CATHETER. TARGET VESSEL: UNKNOWN. IT WAS REPORTED THAT THE IMAGING CATHETER AND GUIDEWIRE TWISTED TOGETHER UPON STARTING LIVE (I.E. MANUAL MODE) IVUS. ON OBSERVING THIS CONDITION, LIVE IVUS WAS IMMEDIATELY STOPPED BY THE OPERATOR. THE CATHETER AND GUIDEWIRE WERE THEN REMOVED FROM THE PATIENT. NO INJURY TO PATIENT REPORTED. NO TREATMENT OF PATIENT REQUIRED DUE TO MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358739 | TVC INSIGHT XB¿ | ULTRASONIC PULSED ECHO IMAGING SYSTEM DIAGNOSTIC INTRAVASCULAR CATHETER | OBJ | INFRAREDX, INC. | TVC-C195-32 | 4601344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |