FDA Adverse Event
Injury
Summary report: N
SWAN-GANZ CONTINUOUS OUTPUT CATHETER
MDR report key: 1233855
·
Received November 12, 2008
Report
- Report Number
- 6000002-2008-09272
- Event Type
- Injury
- Date Received
- November 12, 2008
- Date of Event
- October 20, 2008
- Report Date
- October 20, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYG
- PMA / PMN Number
- K934742
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS POSSIBLE THAT CATHETER MAY HAVE PERFORATED THE PULMONARY ARTERY DURING OFF-PUMP CORONARY ARTERY BYPASS OPERATION. NO OTHER DETAILS WERE PROVIDED FROM THE CUSTOMER. THE DEVICE WILL NOT BE RETURNED FROM CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ CONTINUOUS OUTPUT CATHETER | CONTINUOUS CARDIAC OUTPUT CATHETER | DYG | EDWARDS LIFESCIENCES | 746HF8 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |