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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, neurovasculature
Regulation Description Percutaneous catheter.
Definition To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Product CodeQJP
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMEDICAL BEIJING , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ALEMBIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANOXIA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AQURE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAHI INTECC.CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 4
BEND IT TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJI SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU EASYCESS MEDICAL CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 5
KAI MEDTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
MADURO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MARBLEHEAD MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MARBLEHEAD MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MIVI NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEURAVI LIMITED
  SUBSTANTIALLY EQUIVALENT 2
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 5
PERFUZE, LTD.
  SUBSTANTIALLY EQUIVALENT 4
PIRAEUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
REV NEURO, LLC
  SUBSTANTIALLY EQUIVALENT 1
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
SCIENTIA VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SPARTAN MICRO
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 7
UNITY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 28 28
2022 30 30
2023 75 76
2024 125 125
2025 599 599

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 382 382
Adverse Event Without Identified Device or Use Problem 172 173
Crack 73 73
Material Twisted/Bent 58 58
Material Deformation 44 44
Break 44 44
Difficult to Advance 42 42
Material Separation 34 34
Fluid/Blood Leak 21 21
Burst Container or Vessel 19 19
Deformation Due to Compressive Stress 15 15
Stretched 14 14
No Apparent Adverse Event 14 14
Fracture 13 13
Deflation Problem 13 13
Unintended Movement 12 12
Difficult to Remove 10 10
Insufficient Information 9 9
Device Damaged by Another Device 7 7
Inflation Problem 6 6
Material Too Soft/Flexible 6 6
Device-Device Incompatibility 5 5
Failure to Deflate 5 5
Retraction Problem 4 4
Leak/Splash 4 4
Packaging Problem 4 4
Wrong Label 4 4
Product Quality Problem 3 3
Material Rupture 3 3
Unsealed Device Packaging 3 3
Collapse 3 3
Peeled/Delaminated 3 3
Flaked 3 3
Contamination /Decontamination Problem 2 2
Separation Problem 2 2
Material Integrity Problem 2 2
Entrapment of Device 2 2
Device Dislodged or Dislocated 2 2
Failure to Advance 2 2
Material Split, Cut or Torn 2 2
Material Fragmentation 1 1
Expiration Date Error 1 1
Detachment of Device or Device Component 1 1
Delivered as Unsterile Product 1 1
Air/Gas in Device 1 1
Defective Component 1 1
Malposition of Device 1 1
Unintended Ejection 1 1
Component or Accessory Incompatibility 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 663 663
Intracranial Hemorrhage 51 51
Ischemia Stroke 38 38
Vascular Dissection 26 27
Vasoconstriction 25 25
Obstruction/Occlusion 21 21
Headache 21 21
Thromboembolism 19 19
Embolism/Embolus 16 16
Hemorrhage/Bleeding 16 16
Hematoma 15 15
Stroke/CVA 14 15
Swelling/ Edema 13 13
Hemorrhagic Stroke 12 12
Ischemia 12 12
Pain 10 10
Perforation of Vessels 9 9
Bacterial Infection 9 9
Aneurysm 8 8
Visual Disturbances 8 8
Thrombosis/Thrombus 7 7
Fistula 7 7
No Consequences Or Impact To Patient 7 7
Foreign Body In Patient 7 7
Insufficient Information 6 6
Dysphasia 6 6
Paresis 6 6
Transient Ischemic Attack 5 5
Stenosis 5 5
Rupture 5 5
Confusion/ Disorientation 5 5
Unspecified Nervous System Problem 4 4
Muscle Weakness 4 4
Paralysis 4 4
Nausea 4 4
Bruise/Contusion 4 4
Ruptured Aneurysm 4 4
Respiratory Insufficiency 4 4
Inflammation 3 3
Fever 3 3
Skin Discoloration 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cerebral Edema 3 3
Cardiac Arrest 3 3
Pseudoaneurysm 3 3
Dizziness 3 3
Blurred Vision 3 3
Nervous System Injury 2 2
Perforation 2 2
Vitreous Floaters 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medos International Sarl I Mar-13-2024
2 ROUTE 92 MEDICAL INC I Apr-24-2024
3 Scientia Vascular, Inc. II Feb-26-2025
4 Stryker Neurovascular II Oct-07-2024
5 Stryker Neurovascular II May-28-2024
6 Stryker, Inc. II Feb-14-2024
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