FDA Adverse Event
Other
Summary report: N
ANTIPLEGIA CANNULA
MDR report key: 376056
·
Received February 8, 2002
Report
- Report Number
- 6000002-2002-00058
- Event Type
- Other
- Date Received
- February 8, 2002
- Report Date
- January 9, 2002
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGEON MADE A LITTLE HOLE IN THE POSTERIOR SIDE OF THE AORTA WITH THE NEEDLE OF THE ATC018 DURING THE INSERTION PROCESS. THE SURGEON SUTURED THE HOLE BEFORE CONTINUING THE OPERATION. REPORTEDLY NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANTIPLEGIA CANNULA | ANTEPLEGIA CARDIOPLEGIA DELIVERY | DWF | EDWARDS LIFESCIENCES | ATC018 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |