FDA Adverse Event
Malfunction
Summary report: N
SWAN-GANZ PACEPORT PACEPORT OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD
MDR report key: 1062673
·
Received June 16, 2008
Report
- Report Number
- 6000002-2008-07575
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- April 30, 2008
- Report Date
- May 2, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYG
- PMA / PMN Number
- K905458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED.
Description of Event or Problem · 1
REPORTEDLY, ACCORDING TO THE CUSTOMER, THE BALLOON DETACHED WHEN INFLATING. THIS HAS HAPPENED FOUR TIMES (WITH FOUR DIFFERENT CATHETERS), THE REPORTED COMPLAINT AND SAMPLE IS FROM THE LAST INCIDENT, WHICH IS ONLY ONE SAVED. A NEW REPORT WILL BE INITIATED FOR THE OTHER THREE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWAN-GANZ PACEPORT PACEPORT OXIMETRY TD CATHETER WITH AMC THROMBOSHIELD | THERMODILUTION CATHETER | DYG | EDWARDS LIFESCIENCES, PR | 783HF75 | 58325226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |