FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW 7 XB
MDR report key: 2982905
·
Received February 22, 2013
Report
- Report Number
- 2242352-2013-00130
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Report Date
- January 29, 2013
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVAL CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 XB DISSECTING TIP HAD NO DISCERNIBLE POINT OF REFERENCE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL DOES NOT INTEND TO RETURN THE PRODUCT IN QUESTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77648 | VASOVIEW 7 XB | ENDOSCOPIC VESSEL HARVISTING | GEI | MAQUET CARDIOVASCULAR, LLC | VH-3200 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |