FDA Adverse Event
Injury
Summary report: N
TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM
MDR report key: 1061306
·
Received June 13, 2008
Report
- Report Number
- 1828100-2008-00333
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 12, 2008
- Report Date
- June 12, 2008
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP.
- Product Code
- GCJ
- PMA / PMN Number
- K031891
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING USE OF THE DEVICE FOR ENDOSCOPIC SAPHENOUS VEIN HARVESTING, THE USER REPORTED THE QUALITY OF THE VESSEL HARVESTED WAS UNSUITABLE FOR USE AS A CORONARY ARTERY BYPASS GRAFT. AS A RESULT OF THE DAMAGED VESSEL, THE USER PERFORMED ADDITIONAL VESSEL HARVESTING ON THE OTHER LEG. THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM | ENDOSCOPIC VEIN HARVESTER | GCJ | TERUMO CARDIOVASCULAR SYSTEMS CORP. | MCVS550 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |