MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Mar 17, 2008 · Event occurred Mar 11, 2008
Report 3004936110-2008-00001 · MDR key 1016098
Device
Product problems
- Difficult To Position
Patient
74 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
THE SENSOR WAS DELIVERED TO THE AAA WITH NO ISSUES. UPON DELIVERY OF THE CONTRALATERAL LIMB OF THE STENT GRAFT, THE LIMB WAS UNABLE TO BE POSITIONED PROPERLY BECAUSE THE GUIDEWIRE FOR THE LIMB WAS WRAPPED AROUND THE SENSOR DELIVERY SYSTEM. BOTH THE SENSOR DELIVERY SYSTEM AND THE CONTRALATERAL LIMB WERE REMOVED FROM THE PT. THE LIMB WAS REINTRODUCED WITHOUT ISSUES. THE SENSOR WAS NOT PLACED IN THE PT. THE CASE WAS COMPLETED WITHOUT ANY FURTHER ISSUE.