FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER
MDR report key: 1041359
·
Received May 8, 2008
Report
- Report Number
- 6000002-2008-07128
- Event Type
- Malfunction
- Date Received
- May 8, 2008
- Date of Event
- April 12, 2008
- Report Date
- April 17, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, DURING THE BYPASS SURGERY, CATHETER GOT LOOPED IN THE RIGHT VENTRICLE. CUSTOMER USED THE SNARE CATHETER TO UNDO THE LOOP AND REMOVED THE CATHETER. NO PATIENT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT CATHETER | CONTINUOUS CARDIAC OUTPUT CATHETER | DYG | EDWARDS LIFESCIENCES, PR | 139HF75 | 58482371 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |