InjuryNCA
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Received Aug 25, 2009 · Event occurred Jul 27, 2009
Report 3004114958-2009-00006 · MDR key 1450048
Device
Generic name
Cardiovascular Surgical Instrument
Manufacturer
Cardica, Inc.Model number
FG-000001-09Catalog number
UNK
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
- Perforation
Narrative
Description of Event or Problem
THIS WAS A CABG CASE. UPON FIRING THE CUTTER OF THE PAS-PORT DEVICE, THE PHYSICIAN NOTICED AN EXCESS OF BLEEDING AND DESCRIBED THE SIZE OF THE HOLE ON THE AORTA AS ABOUT THE SIZE OF AN INDEX AND MIDDLE FINGER WIDTH. THE HOLE WAS CIRCULAR. PHYSICIAN CLOSED THE HOLE AND HAND SEWED THE GRAFT IN A DIFFERENT LOCATION. THE PHYSICIAN NOTED THAT THERE WAS NOTHING VERY PECULIAR ABOUT THE PARTICULAR ANATOMY OF THE PATIENT.