FDA Adverse Event
Injury
Summary report: N
MERIDAN FILTER SYSTEM - JUGULAR
MDR report key: 2832970
·
Received November 5, 2012
Report
- Report Number
- 2020394-2012-00250
- Event Type
- Injury
- Date Received
- November 5, 2012
- Date of Event
- October 9, 2012
- Report Date
- October 11, 2012
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K102511
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEPLOYMENT OF A VENA CAVA FILTER, THE DELIVERY HUB PULLED AWAY FROM THE INTRODUCER HUB, WHICH RESULTED IN THE FILTER BEING MISDEPLOYED IN THE RIGHT ILIAC VEIN AS THE TWO HUBS WERE RECONNECTED. A SNARE WAS USED TO REMOVE THE FILTER WITHOUT INCIDENT AND ANOTHER FILTER WAS SUCCESSFULLY DEPLOYED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIDAN FILTER SYSTEM - JUGULAR | DTK | BARD PERIPHERAL VASCULAR, INC. | GFWB4349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 98 YR |