FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
MDR report key: 1060737
·
Received June 11, 2008
Report
- Report Number
- 6000002-2008-07537
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Date of Event
- April 14, 2008
- Report Date
- April 18, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. THE BALLOON WAS FOUND TO INFLATE BUT WOULD NOT MAINTAIN INFLATION DUE TO LEAKAGE FROM A SLIT 0.015" LONG AT THE DISTAL EDGE OF THE THERMAL FILAMENT (MIDDLE FORM) AREA. THE SLIT ENTERS THE INFLATION LUMEN. A CAPA IS IN PROCESS FOR SLIT IN CATHETER BODY RELATED TO BALLOON INFLATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE AND THE BALLOON COULD NOT MAINTAIN INFLATION. NO PT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER | CONTINUOUS CARDIAC OUTPUT CATHETER | DYB | EDWARDS LIFESCIENCES, PR | 746HF8 | 58343097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |