FDA Adverse Event
Injury
Summary report: N
CLARIVEIN IC INFUSION CATHETER
MDR report key: 6944088
·
Received October 12, 2017
Report
- Report Number
- 3005831739-2017-00012
- Event Type
- Injury
- Date Received
- October 12, 2017
- Date of Event
- August 25, 2017
- Report Date
- October 11, 2017
- Manufacturer
- VASCULAR INSIGHTS LLC
- Product Code
- KRA
- UDI-DI
- 10854339004027
- PMA / PMN Number
- K071468
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CLARIVEIN DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THERE WERE NO ISSUES CITED WITH DEVICE PERFORMANCE. POTENTIAL ADVERSE EFFECTS THAT MIGHT BE ASSOCIATED WITH THE CLARIVEIN® DEVICE ARE SIMILAR TO THOSE ASSOCIATED WITH ANY INTERVENTIONAL VASCULAR PROCEDURE. THE IFU PROVIDED WITH THE CLARIVEIN DEVICE LISTS THE POTENTIAL ADVERSE EVENTS THAT MIGHT BE ENCOUNTERED DURING A PERIPHERAL VASCULATURE INFUSION PROCEDURE USING THE CLARIVEIN® IC AS WELL AS INSTRUCTS THE USER TO CONSULT LABELING OF AGENTS TO BE DELIVERED PRIOR TO INFUSION.
Description of Event or Problem · 1
DURING A ROUTINE FOLLOW-UP RIGHT LEG, POPLITEAL AND DISTAL FEMORAL VEIN DVT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724020 | CLARIVEIN IC INFUSION CATHETER | CLARIVEIN IC INFUSION CATHETER | KRA | VASCULAR INSIGHTS LLC | 65-018-E4S | BM651404816I | 10854339004027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |