FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
MDR report key: 1378025
·
Received May 11, 2009
Report
- Report Number
- 2015691-2009-10540
- Event Type
- Malfunction
- Date Received
- May 11, 2009
- Date of Event
- April 17, 2009
- Report Date
- April 17, 2009
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- PMA / PMN Number
- K812563
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER REPORT WAS CONFIRMED. THE BALLOON HAS RUPTURED IN THE CENTRAL AREA. THERE IS NO MISSING LATEX AND BOTH BALLOON BONDS ARE INTACT.
Description of Event or Problem · 1
C-CC-BA - BALLOON DAMAGE OR OUT OF SPEC SGC-0904-012; BALLOON RUPTURED IN RIGHT ATRIUM. THERE IS A POSSIBILITY THAT THE PIECE OF BALLOON LATEX REMAINED IN PATIENT BODY. NO COMPLICATIONS REPORTED AT THIS MOMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ THERMODILUTION CATHETER WITH AMC THROMBOSHIELD | THERMODILUTION CATHETER | DYG | EDWARDS LIFESCIENCES, PR | TS057HF7 | 58534786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |