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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary coil embolization assist device
Definition A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
Product CodePUU
Regulation Number 882.5955
Device Class 2


Premarket Reviews
ManufacturerDecision
RAPID-MEDICAL LTD.
  GRANTED 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 5 5
2022 6 6
2023 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17 17
Entrapment of Device 2 2
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Off-Label Use 1 1
Separation Failure 1 1
Unintended Movement 1 1
Obstruction of Flow 1 1
Device Damaged by Another Device 1 1
Migration 1 1
Difficult to Open or Close 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 11 11
Thrombosis/Thrombus 3 3
Hemorrhage/Bleeding 3 3
Stroke/CVA 2 2
Obstruction/Occlusion 2 2
Laceration(s) 2 2
Device Embedded In Tissue or Plaque 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Known Impact Or Consequence To Patient 1 1
Foreign Body In Patient 1 1
Failure to Anastomose 1 1

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