FDA Adverse Event
Injury
Summary report: N
CLARIVEIN
MDR report key: 4095880
·
Received September 5, 2014
Report
- Report Number
- 3005831739-2014-00004
- Event Type
- Injury
- Date Received
- September 5, 2014
- Date of Event
- August 4, 2014
- Report Date
- September 3, 2014
- Manufacturer
- VASCULAR INSIGHTS LLC
- Product Code
- KRA
- PMA / PMN Number
- 071468
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED THAT THERE WERE NO ISSUES CITED WITH THE DEVICES PERFORMANCE.
Description of Event or Problem · 1
A DVT WAS OBSERVED ON (B)(6) 2014 DURING THE NORMAL FOLLOW UP TO A PROCEDURE ON (B)(6) 2014. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT WAS PLACED ON ORAL ANTICOAGULANT (XARELTO). UPON A RETURN VISIT ON (B)(6), IT WAS DETERMINED THAT THE DVT WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543534 | CLARIVEIN | CONTINOUS FLUSH CATHETER | KRA | VASCULAR INSIGHTS LLC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |