FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE FILTER SYSTEM - FEMORAL
MDR report key: 2220528
·
Received July 18, 2011
Report
- Report Number
- 2020394-2011-00161
- Event Type
- Malfunction
- Date Received
- July 18, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 20, 2011
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- DTK
- PMA / PMN Number
- K101431
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SCHEDULED RETRIEVAL OF AN IVC FILTER, IMAGING DEMONSTRATED THAT A FILTER LIMB WAS DETACHED AND WAS LOCATED WITHIN THE IVC. THE FILTER WAS SUCCESSFULLY RETRIEVED WITHOUT INCIDENT. THE DETACHED LIMB REMAINS IMPLANTED. NO REPORT OF INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECLIPSE FILTER SYSTEM - FEMORAL | DTK | BARD PERIPHERAL VASCULAR, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |