FDA Adverse Event
Malfunction
Summary report: N
GUNTHER TULIP VENA CAVA FILTER SET - JUGULAR APPROACH
MDR report key: 1062785
·
Received June 17, 2008
Report
- Report Number
- 1820334-2008-00322
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 22, 2008
- Report Date
- May 23, 2008
- Manufacturer
- COOK, INC.
- Product Code
- DTK
- PMA / PMN Number
- K000855
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE PT WHO WAS SOMEWHAT OBESE WITH LOWER EXTREMITY DVT NEEDED A FILTER PLACED. DURING THE FILTER PLACEMENT, THE PATIENT'S HEAD WAS NOT TURNED AND THE ANGLE WAS EXTREME. THE PHYSICIAN SAW THE FILTER PIERCE THE SHEATH IN THE NECK. THE PHYSICIAN THEN OPENED A SECOND FILTER TO CHANGE THE SHEATH AND THE SAME THING HAPPENED. AFTER A FAILED ATTEMPT TO ADVANCE THE ENTIRE ASSEMBLY, THE PHYSICIAN PUT A 10 FRENCH SHEATH IN THE IVC AND PASSED THE TULIP FILTER THROUGH THIS AND THEN THE FILTER WAS PLACED WITHOUT INCIDENT (SEE ALSO 1820334-2008-00323). PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUNTHER TULIP VENA CAVA FILTER SET - JUGULAR APPROACH | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |