DEVICE, HEMOSTASIS, VASCULAR
This device is manufactured by ACCESSCLOSURE, ACCESSCLOSURE A CARDINAL HEALTH COMPANY, CARDINAL HEALTH, CARDINAL HEALTH SANTA CLARA, CORDIS CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2023 | Separation Failure | 1 | Device |
| 2023 | Retraction Problem | 1 | Device |
| 2023 | Positioning Failure | 2 | Device |
| 2023 | Migration | 1 | Device |
| 2023 | Failure to Advance | 1 | Device |
| 2022 | Paresthesia | 1 | Patient |
| 2022 | Numbness | 1 | Patient |
| 2022 | Local Reaction | 1 | Patient |
| 2022 | Separation Failure | 2 | Device |
| 2022 | Positioning Failure | 3 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Rupture | 4 | Device |
| 2022 | Material Frayed | 1 | Device |
| 2022 | Failure to Fire | 5 | Device |
| 2022 | Failure to Deliver | 1 | Device |
| 2022 | Failure to Advance | 1 | Device |
| 2022 | Entrapment of Device | 1 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Decrease in Pressure | 4 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Unintended Movement | 5 | Device |
| 2019 | Therapy Delivered to Incorrect Body Area | 2 | Device |
| 2019 | Separation Failure | 6 | Device |
| 2019 | Retraction Problem | 9 | Device |
| 2019 | Positioning Failure | 44 | Device |
| 2019 | Migration or Expulsion of Device | 7 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Material Rupture | 24 | Device |
| 2019 | Material Puncture/Hole | 3 | Device |
| 2019 | Insufficient Information | 1 | Device |
| 2019 | Failure to Advance | 15 | Device |
| 2019 | Difficult to Advance | 4 | Device |
| 2019 | Difficult or Delayed Positioning | 4 | Device |
| 2019 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2019 | Detachment of Device or Device Component | 1 | Device |
| 2019 | Deflation Problem | 4 | Device |
| 2019 | Defective Component | 7 | Device |
| 2019 | Decrease in Pressure | 7 | Device |
| 2019 | Component Missing | 5 | Device |
| 2019 | Burst Container or Vessel | 4 | Device |
| 2019 | Appropriate Term/Code Not Available | 17 | Device |
| 2019 | Activation, Positioning or Separation Problem | 6 | Device |
| 2019 | Activation Problem | 1 | Device |
| 2018 | Unintended Movement | 4 | Device |
| 2018 | Therapy Delivered to Incorrect Body Area | 5 | Device |
| 2018 | Separation Failure | 12 | Device |
| 2018 | Retraction Problem | 9 | Device |
| 2018 | Premature Activation | 1 | Device |
| 2018 | Positioning Failure | 42 | Device |
| 2018 | Patient Device Interaction Problem | 1 | Device |
| 2018 | Migration or Expulsion of Device | 8 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Rupture | 15 | Device |
| 2018 | Material Puncture/Hole | 1 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Failure to Deliver | 1 | Device |
| 2018 | Failure to Advance | 20 | Device |
| 2018 | Expulsion | 2 | Device |
| 2018 | Difficult to Advance | 2 | Device |
| 2018 | Difficult or Delayed Positioning | 1 | Device |
| 2018 | Device Slipped | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 2 | Device |
| 2018 | Device Dislodged or Dislocated | 2 | Device |
| 2018 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Deflation Problem | 2 | Device |
| 2018 | Defective Component | 2 | Device |
| 2018 | Decrease in Pressure | 8 | Device |
| 2018 | Crack | 3 | Device |
| 2018 | Component Missing | 6 | Device |
| 2018 | Burst Container or Vessel | 3 | Device |
| 2018 | Appropriate Term/Code Not Available | 4 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2018 | Activation, Positioning or Separation Problem | 4 | Device |
| 2017 | Unintended Movement | 6 | Device |
| 2017 | Therapy Delivered to Incorrect Body Area | 3 | Device |
| 2017 | Separation Failure | 1 | Device |
| 2017 | Retraction Problem | 6 | Device |
| 2017 | Positioning Failure | 42 | Device |
| 2017 | Migration or Expulsion of Device | 4 | Device |
| 2017 | Material Rupture | 1 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Inflation Problem | 2 | Device |
| 2017 | Failure to Advance | 9 | Device |
| 2017 | Expulsion | 1 | Device |
| 2017 | Entrapment of Device | 1 | Device |
| 2017 | Difficult to Remove | 1 | Device |
| 2017 | Difficult to Advance | 2 | Device |
| 2017 | Detachment of Device or Device Component | 2 | Device |
| 2017 | Deflation Problem | 6 | Device |
| 2017 | Defective Component | 1 | Device |
| 2017 | Decrease in Pressure | 2 | Device |
| 2017 | Component Missing | 20 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 13 | Device |
| 2017 | Activation, Positioning or Separation Problem | 7 | Device |
| 2016 | Unintended Movement | 2 | Device |
| 2016 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2016 | Sticking | 1 | Device |
| 2016 | Separation Failure | 11 | Device |
| 2016 | Retraction Problem | 15 | Device |
| 2016 | Positioning Failure | 15 | Device |
| 2016 | Migration or Expulsion of Device | 1 | Device |
| 2016 | Material Rupture | 2 | Device |
| 2016 | Failure to Advance | 5 | Device |
| 2016 | Difficult to Remove | 4 | Device |
| 2016 | Difficult to Advance | 3 | Device |
| 2016 | Device Operates Differently Than Expected | 4 | Device |
| 2016 | Deflation Problem | 1 | Device |
| 2016 | Defective Component | 1 | Device |
| 2016 | Component Missing | 2 | Device |
| 2016 | Burst Container or Vessel | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2016 | Activation, Positioning or Separation Problem | 4 | Device |
| 2015 | Sticking | 2 | Device |
| 2015 | Pressure Problem | 1 | Device |
| 2015 | Positioning Failure | 1 | Device |
| 2015 | Physical Resistance | 2 | Device |
| 2015 | No Pressure | 6 | Device |
| 2015 | Material Rupture | 1 | Device |
| 2015 | Insufficient Information | 1 | Device |
| 2015 | Failure to Fire | 1 | Device |
| 2015 | Failure to Advance | 1 | Device |
| 2015 | Device Operates Differently Than Expected | 5 | Device |
| 2015 | Detachment Of Device Component | 1 | Device |
| 2015 | Deflation Problem | 1 | Device |
| 2015 | Decrease in Pressure | 1 | Device |
| 2015 | Burst Container or Vessel | 1 | Device |
| 2015 | Break | 1 | Device |
| 2014 | Positioning Failure | 1 | Device |
| 2014 | Material Rupture | 1 | Device |
| 2014 | Insufficient Information | 1 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Connection Problem | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | Material Separation | 1 | Device |
| 2013 | Material Rupture | 2 | Device |
| 2013 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 1 | Device |
| 1980 | Positioning Failure | 3 | Device |
| 1980 | Migration or Expulsion of Device | 1 | Device |
| 1980 | Material Rupture | 3 | Device |
| 1980 | Failure to Advance | 1 | Device |
| 1980 | Deflation Problem | 3 | Device |
| 1980 | Decrease in Pressure | 3 | Device |