Risk Index Table
Initial Hazard Analysis
Potential hazards:
• Guide wires and sheaths confused due to similar size and improper labeling
• Incorrect filter size is chosen, leading to arterial tear or spasm due to faulty assessment of vessel size
• Filter is incorrectly placed, either too close or too far from clot, due to insufficient viewing techniques and lack of training
• Little capture of emboli due to improper positioning of filter because of incorrect placement
• Loss of emboli during retrieval of filter due to insufficiency of capturing component and lack of training
Risk Index Table
|Probability of Occurrence |Severity I |Severity II |Severity III Marginal |Severity IV |
| |Catastrophic (death, |Significant (reversible |(inconvenience) |Negligible |
| |serious injury) |serious injury) | | |
|Frequent |1 |3 |6 |10 |
|Probable |2 |4 |8 |14 |
|Occasional |3 |7 |11 |17 |
|Remote |7 |11 |16 |19 |
|Improbable |10 |16 |18 |20 |
|Hazard Risk Index |Acceptance Criteria |
|1 to 5 |Unacceptable |
|6 to 9 |Undesirable: written and reviewed decision required to proceed |
|10 to 16 |Acceptable upon completion of quality assurance review |
|17 to 20 |Acceptable without review |
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