FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD
MDR report key: 1172363
·
Received September 19, 2008
Report
- Report Number
- 6000002-2008-08700
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 28, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- PMA / PMN Number
- K791183
- 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
IT WAS REPORTED THAT THE CUSTOMER INSERTED THE CATHETER THROUGH AN (ADVANCED VENOUS ACCESS DEVICE). WHEN THE CLINICIAN TRIED TO ADJUST THE CATHETER, MODEL # D205HF7 CATHETER GOT STUCK BETWEEN #1 AND #2 ELECTRODE AND IT WAS DIFFICULT TO REMOVE THE CATHETER FROM AVA. AVA DEVICE WAS DISCARDED. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD | THERMODILUTION CATHETER | DYG | EDWARDS LIFESCIENCES, PR | D205HF7 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |