FDA Adverse Event
Injury
Summary report: N
MERIDAN FILTER SYSTEM-JUGULAR
MDR report key: 3940962
·
Received April 23, 2014
Report
- Report Number
- 2020394-2014-00186
- Event Type
- Injury
- Date Received
- April 23, 2014
- Date of Event
- March 11, 2014
- Report Date
- March 26, 2014
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K102511
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON DEPLOYMENT OF A VENA CAVA FILTER, THE FILTER MIGRATED TO THE RENAL VEINS AND BECAME TILTED, AND THE FILTER DID NOT COMPLETELY EXPAND. THE FILTER WAS RETRIEVED PERCUTANEOUSLY WITH FORCEPS. THERE IS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245453 | MERIDAN FILTER SYSTEM-JUGULAR | DTK | BARD PERIPHERAL VASCULAR, INC. | GFXH2786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |