FDA Adverse Event
Malfunction
Summary report: N
VARI-LASE PROCEDURE KIT
MDR report key: 2883964
·
Received December 21, 2012
Report
- Report Number
- 2134812-2012-00051
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 30, 2012
- Report Date
- December 21, 2012
- Manufacturer
- VASCULAR SOLUTIONS, INC.
- Product Code
- GEX
- PMA / PMN Number
- 070216
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A VARI-LASE PROCEDURE KIT WAS BEING USED IN A CLINICAL PROCEDURE WHEN THE PATIENT REPORTED DISCOMFORT. THE PHYSICIAN WITHDREW THE TREATMENT SYSTEM AND NOTICED THAT THE LASER FIBER WAS PROTRUDING FROM THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VARI-LASE PROCEDURE KIT | LASER FIBER- STANDARD PROCEDURE KIT | GEX | VASCULAR SOLUTIONS, INC. | 7114 | 560201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |