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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