FDA Adverse Event
Death
Summary report: N
CORONARY IMAGING CATHETER
MDR report key: 299334
·
Received October 9, 2000
Report
- Report Number
- 6000084-2000-00002
- Event Type
- Death
- Date Received
- October 9, 2000
- Date of Event
- September 5, 2000
- Report Date
- October 7, 2000
- Manufacturer
- SCIMED. A DIV OF BSC
- Product Code
- DQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE REPORT TO THE MFR DESCRIBED: "FIVE MINUTES AFTER SUCCESSFULLY IMAGING, THE PT EXPERIENCED LOSS OF BLOOD PRESSURE AND "WENT INTO DEFIB". PT WAS SENT TO SURGERY AND IS STILL ON BALLOON PUMP. IT IS UNCLEAR HOW THE CATHETER PERFORMANCE WAS RELATED TO THE INCIDENT." A FOLLOW UP WAS MADE ON 09/27/2000, AND THE FOLLOWING INFO WAS OBTAINED FROM THE PHYSICIAN: PT EXPIRED ON 09/25/2000. THE IMAGING CATHETER DID NOT CONTRIBUTE TO THE OCCURRENCE. THE CATHETER WAS NOT PRESENT (IN PT) AT THE TIME OF INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORONARY IMAGING CATHETER | INTRAVASCULAR ULTRASOUND CATHETER SYSTEM | DQO | SCIMED. A DIV OF BSC | C2018 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |