FDA Adverse Event
Injury
Summary report: N
CLARIVEIN
MDR report key: 3190844
·
Received June 21, 2013
Report
- Report Number
- 3005831739-2013-00001
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- May 21, 2013
- Report Date
- June 18, 2013
- Manufacturer
- VASCULAR INSIGHTS LLC
- Product Code
- KRA
- PMA / PMN Number
- 071468
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DVT IS A KNOWN POTENTIAL ADVERSE EVENT IN INTERVENTIONAL PROCEDURES AND IS NOT RELATED TO A DEVICE FAILURE.
Description of Event or Problem · 1
ON (B)(6) 2013, (B)(6), MD PERFORMED AN ABLATION PROCEDURE USING THE CLARIVEIN CATHETER ON A (B)(6). HE TREATED 65CM WITH 5CC OF 2% POLIDOCANOL. UPON FOLLOW UP THE PT WAS OBSERVED TO HAVE A DVT THAT RAN FROM THE SFJ TO ABOUT 10CM DISTAL IN THE FEMORAL VEIN. THE FEMORAL VEIN WAS ABOUT 60% OCCLUDED, BUT STILL HAD FLOW. DR. (B)(6) HAS TREATED THE PT FOR DVT AND SCHEDULED FOLLOW UP CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282561 | CLARIVEIN | CONTINUOUS FLUSH CATHETER | KRA | VASCULAR INSIGHTS LLC | 65-018-E4S | ME651401731I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |