FDA Adverse Event
Malfunction
Summary report: N
G2X FILTER SYSTEM
MDR report key: 2110117
·
Received May 19, 2011
Report
- Report Number
- 2020394-2011-00097
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Report Date
- April 6, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K082305
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CT SCAN HAD DEMONSTRATED THAT A FILTER LEG HAD DETACHED FROM THE REST OF THE IVC FILTER. REPORTEDLY, THE FINDING WAS INCIDENTAL AND THE PT WAS ASYMPTOMATIC. FURTHER INFO IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | G2X FILTER SYSTEM | DTK | BARD PERIPHERAL VASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |