FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH AMC THROMBOSHI
MDR report key: 1052001
·
Received May 21, 2008
Report
- Report Number
- 6000002-2008-07276
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 1, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- PMA / PMN Number
- K812563
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BALLOON COULD NOT INFLATE PROPERLY WHILE IN THE PT. IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE. NO PT COMPLICATIONS WERE REPORTED. FOLLOWED INDICATED THAT THE BALLOON WOULD NOT DEFLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH AMC THROMBOSHI | THERMODILUTION CATHETER | DYG | EDWARDS LIFESCIENCES, PR | 831HF75 | 58462739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |