FDA Adverse Event
Summary report: N
VASOVIEW 6 EVH SYSTEM
MDR report key: 2222779
·
Received August 10, 2011
Report
- Report Number
- 2242352-2011-01099
- Date Received
- August 10, 2011
- Report Date
- July 26, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE EVAL IS COMPLETE. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 6 WOULD NOT WORK. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW 6 EVH SYSTEM | ENDOSCOPIC VESSEL HARVESTING SYSTEM | GEI | MAQUET CARDIOVASCULAR, LLC. | VH-2000 | 0300001309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |