HEMOSTASIS VASCULAR DEVICE
This device is manufactured by TERUMO MEDICAL CORPORATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Pseudoaneurysm | 2 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Obstruction/Occlusion | 1 | Patient |
| 2024 | Insufficient Information | 4 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2024 | Hematoma | 3 | Patient |
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Diminished Pulse Pressure | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Ambulation Difficulties | 1 | Patient |
| 2024 | Patient Device Interaction Problem | 1 | Device |
| 2024 | Migration | 2 | Device |
| 2024 | Material Fragmentation | 1 | Device |
| 2024 | Material Deformation | 3 | Device |
| 2024 | Loosening of Implant Not Related to Bone-Ingrowth | 1 | Device |
| 2024 | Difficult to Insert | 1 | Device |
| 2024 | Crack | 4 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2024 | Activation, Positioning or Separation Problem | 6 | Device |
| 2024 | Activation Problem | 1 | Device |
| 2024 | Activation Failure | 12 | Device |
| 2023 | Vascular Dissection | 2 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Stenosis | 1 | Patient |
| 2023 | Retroperitoneal Hemorrhage | 2 | Patient |
| 2023 | Pseudoaneurysm | 3 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Obstruction/Occlusion | 5 | Patient |
| 2023 | Numbness | 1 | Patient |
| 2023 | Limb Pain | 1 | Patient |
| 2023 | Laceration(s) | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Idiopathic Intracranial Hypertension | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 11 | Patient |
| 2023 | Hematoma | 15 | Patient |
| 2023 | Foreign Body In Patient | 4 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Diminished Pulse Pressure | 4 | Patient |
| 2023 | Aneurysm | 1 | Patient |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Physical Resistance/Sticking | 1 | Device |
| 2023 | Obstruction of Flow | 1 | Device |
| 2023 | Migration or Expulsion of Device | 2 | Device |
| 2023 | Migration | 2 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Loosening of Implant Not Related to Bone-Ingrowth | 8 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Seal | 11 | Device |
| 2023 | Difficult to Insert | 3 | Device |
| 2023 | Difficult to Advance | 1 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Break | 4 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Activation, Positioning or Separation Problem | 65 | Device |
| 2023 | Activation Problem | 8 | Device |
| 2023 | Activation Failure | 6 | Device |
| 2022 | Thrombosis/Thrombus | 1 | Patient |
| 2022 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2022 | Swelling/ Edema | 1 | Patient |
| 2022 | Retroperitoneal Hemorrhage | 1 | Patient |
| 2022 | Nodule | 1 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Inflammation | 1 | Patient |
| 2022 | Implant Pain | 1 | Patient |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Material Separation | 1 | Device |
| 2022 | Material Deformation | 4 | Device |
| 2022 | Loosening of Implant Not Related to Bone-Ingrowth | 5 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2022 | Activation, Positioning or Separation Problem | 11 | Device |
| 2022 | Activation Problem | 8 | Device |
| 2022 | Activation Failure | 12 | Device |
| 2019 | Separation Problem | 1 | Device |
| 2019 | Premature Activation | 2 | Device |
| 2019 | Physical Resistance/Sticking | 1 | Device |
| 2019 | No Apparent Adverse Event | 2 | Device |
| 2019 | Migration or Expulsion of Device | 1 | Device |
| 2019 | Migration | 1 | Device |
| 2019 | Material Twisted/Bent | 1 | Device |
| 2019 | Material Separation | 2 | Device |
| 2019 | Material Deformation | 10 | Device |
| 2019 | Insufficient Information | 3 | Device |
| 2019 | Fracture | 3 | Device |
| 2019 | Expulsion | 1 | Device |
| 2019 | Difficult to Remove | 6 | Device |
| 2019 | Difficult to Insert | 6 | Device |
| 2019 | Difficult to Advance | 4 | Device |
| 2019 | Difficult or Delayed Activation | 5 | Device |
| 2019 | Detachment of Device or Device Component | 3 | Device |
| 2019 | Component Missing | 3 | Device |
| 2019 | Break | 7 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2019 | Activation, Positioning or Separation Problem | 26 | Device |
| 2019 | Activation Problem | 2 | Device |
| 2019 | Activation Failure | 28 | Device |
| 2018 | Premature Separation | 1 | Device |
| 2018 | Positioning Failure | 12 | Device |
| 2018 | Migration or Expulsion of Device | 1 | Device |
| 2018 | Migration | 2 | Device |
| 2018 | Mechanical Jam | 3 | Device |
| 2018 | Material Separation | 1 | Device |
| 2018 | Material Deformation | 8 | Device |
| 2018 | Kinked | 7 | Device |
| 2018 | Insufficient Information | 2 | Device |
| 2018 | Hole In Material | 1 | Device |
| 2018 | Fracture | 6 | Device |
| 2018 | Entrapment of Device | 2 | Device |
| 2018 | Difficult to Remove | 4 | Device |
| 2018 | Difficult to Insert | 23 | Device |
| 2018 | Difficult to Advance | 4 | Device |
| 2018 | Difficult or Delayed Positioning | 5 | Device |
| 2018 | Difficult or Delayed Activation | 7 | Device |
| 2018 | Device Operates Differently Than Expected | 3 | Device |
| 2018 | Detachment of Device or Device Component | 6 | Device |
| 2018 | Detachment Of Device Component | 7 | Device |
| 2018 | Deformation Due to Compressive Stress | 1 | Device |
| 2018 | Crack | 2 | Device |
| 2018 | Component Missing | 3 | Device |
| 2018 | Break | 4 | Device |
| 2018 | Bent | 3 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 36 | Device |
| 2018 | Activation, Positioning or Separation Problem | 22 | Device |
| 2018 | Activation Problem | 1 | Device |
| 2018 | Activation Failure | 16 | Device |
| 2017 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2017 | Split | 1 | Device |
| 2017 | Positioning Failure | 32 | Device |
| 2017 | Occlusion Within Device | 1 | Device |
| 2017 | Migration or Expulsion of Device | 3 | Device |
| 2017 | Material Fragmentation | 1 | Device |
| 2017 | Kinked | 6 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Entrapment of Device | 1 | Device |
| 2017 | Difficult to Remove | 2 | Device |
| 2017 | Difficult to Insert | 7 | Device |
| 2017 | Difficult or Delayed Positioning | 12 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Operational Issue | 2 | Device |
| 2017 | Device Operates Differently Than Expected | 28 | Device |
| 2017 | Device Issue | 2 | Device |
| 2017 | Device Difficult to Setup or Prepare | 1 | Device |
| 2017 | Detachment of Device or Device Component | 5 | Device |
| 2017 | Detachment Of Device Component | 4 | Device |
| 2017 | Defective Device | 1 | Device |
| 2017 | Connection Problem | 1 | Device |
| 2017 | Component Missing | 9 | Device |
| 2017 | Break | 8 | Device |
| 2017 | Bent | 10 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 20 | Device |
| 2017 | Activation, Positioning or Separation Problem | 27 | Device |