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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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Entrapment of Device 2 2
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Unintended Collision 1 1
Off-Label Use 1 1
Obstruction of Flow 1 1
Separation Failure 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Close 1 1
Unintended Movement 1 1
Migration 1 1

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

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