FDA Adverse Event
Other
Summary report: N
RETROGRADE CARDIOPLEGIA CANNULA
MDR report key: 379236
·
Received February 27, 2002
Report
- Report Number
- 6000002-2002-00098
- Event Type
- Other
- Date Received
- February 27, 2002
- Report Date
- January 28, 2002
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A RUPTURE OF THE CORONARY SINUS. THE SURGEON DOES NOT FEEL THAT THE RC2014LB DEVICE CAUSED THIS RUPTURE. THE RUPTURE WAS REPAIRED WITHOUT SUBSTANTIAL BLOOD LOSS. THE CASE WAS PROLONGED APPROX. 20 MINUTES. THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RETROGRADE CARDIOPLEGIA CANNULA | RETROGRADE CARDIOPLEGIA CANNULA | DWF | EDWARDS LIFESCIENCES | RC2014LB | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |