Chenara Johnson, Daphne Kontos,
Sandeep Devabhakthuni, Perry Tiberio
Function or
Component
Failure
Mode
Effect on
System
Possible Hazards
Risk
Index
Nitinol Ring
Incorrect diameter for the ring
Inability to successfully remove filter due to embedding within the arterial walls.
Failure to catch all embolic particles
Pore size of filter
Pore size is insufficient in complying with size of embolic particles
Small embolic particles pass through filter to the brain
If dissection is severe enough it could cause internal bleeding.
Embolic particles could flow to the brain causing ischemic stroke.
Particles that are not caught by filter cause ischemic stroke and thromboembolism.
8
10
User
Detection
Means
Applicable
Control(s)
Detection will be through machines measuring the homeostasis involving the heart rate and brain activity.
Attention to the diameter of filter chosen in regards to the patient and careful implementation of the ring filter into the artery.
Abnormal brain activity.
Low blood flow.
Assure that the pore sizes are small enough to catch all particles that could cause potential harm.
Filter
Retrieval
Catheter
Clotting behind the filter
Unsteadiness of the retrieval catheter
Build up of embolic particles and restricting blood flow
Embolic particles from filter to be released into the arterial system
Loss in blood pressure and blood flow to the brain
Thromboembolism and possible stroke.
12
8
Heart rate and brain activity will provide information as to show that a physiological problem is occurring.
Use a filter material that is able to prevent clotting and build up of embolic material.
Abnormal brain activity.
Low blood flow.
Training and practice prior to the clinical setting