FDA Adverse Event
Injury
Summary report: N
LIVER ACCESS AND BIOPSY SET
MDR report key: 2090071
·
Received May 5, 2011
Report
- Report Number
- 1820334-2011-00216
- Event Type
- Injury
- Date Received
- May 5, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- COOK, INC.
- Product Code
- FCG
- PMA / PMN Number
- K902319
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PT CONDITION AFTER PROCEDURE WAS NOT PROVIDED. DEVICE SEPARATION IS NOT LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
DURING A LIVER BIOPSY TRANSJUGULAR OF A MALE PT, THE WHITE HUB OF THE INNER CATHETER (BLACK PORTION) CAME OFF, RESULTING IN THE DISTAL END OF THE CATHETER SHEARING. A PIECE OF THE CATHETER WAS FOUND IN THE PT'S BIOPSY SAMPLE. AT THIS TIME, IT IS NOT KNOWN IF ANY REMAINS IN THE PT. NO ADVERSE EFFECTS BACK TO THE WARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIVER ACCESS AND BIOPSY SET | FCG KIT, NEEDLE, BIOPSY | FCG | COOK, INC. | NA | 2615595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |