FDA Adverse Event
Injury
Summary report: N
VASOVIEW 7XB
MDR report key: 1575071
·
Received January 8, 2010
Report
- Report Number
- 2648729-2009-00024
- Event Type
- Injury
- Date Received
- January 8, 2010
- Date of Event
- December 15, 2009
- Report Date
- December 15, 2009
- Manufacturer
- MAQUET PUERTO RICO, B.V.
- Product Code
- GEI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE HOSPITAL.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT TOWARDS THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE PLASTIC TUBE THAT HOLDS THE C-RING IN THE CANNULA OF A VASOVIEW 7XBISECTOR BROKE OFF ON ONE SIDE AND FELL INTO THE PT'S LEG. THE HARVESTER WAS ABLE TO RETRIEVE THE PIECE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VASOVIEW 7XB | VV7 HARVESTING CANNULA | GEI | MAQUET PUERTO RICO, B.V. | VH-3200 | 9050871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |