FDA Adverse Event
Malfunction
Summary report: N
VASOVIEW 7 XB
MDR report key: 3772221
·
Received January 2, 2014
Report
- Report Number
- 2242352-2013-01821
- Event Type
- Malfunction
- Date Received
- January 2, 2014
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2013
- Manufacturer
- MAQUET CARDIOVASCLUAR, INC
- Product Code
- GEI
- PMA / PMN Number
- K041981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THAT HE DISSECTION TIP ON THE VASOVIEW 7 XB WAS CLOUDY. AN ACCESSORY KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2823 | VASOVIEW 7 XB | ENDOSCOPIC VESSEL HARVESTING | GEI | MAQUET CARDIOVASCLUAR, INC | VH-3200 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |