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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
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
KANEKA AMERICAS HOLDING, INC.
  SUBSTANTIALLY EQUIVALENT 1
MADURO MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MARBLEHEAD MEDICAL, LLC
  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
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCIENTIA VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SPARTAN MICRO
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 6
TORO NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VESALIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 29 29
2022 30 30
2023 75 76
2024 126 126
2025 695 695

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 446 446
Adverse Event Without Identified Device or Use Problem 182 183
Crack 71 71
Material Twisted/Bent 60 60
Material Deformation 49 49
Break 46 46
Difficult to Advance 44 44
Retraction Problem 43 43
Material Separation 33 33
Burst Container or Vessel 19 19
Fluid/Blood Leak 17 17
Deformation Due to Compressive Stress 16 16
Stretched 16 16
Unintended Movement 15 15
No Apparent Adverse Event 14 14
Deflation Problem 13 13
Fracture 12 12
Difficult to Remove 12 12
Insufficient Information 9 9
Device Damaged by Another Device 8 8
Material Too Soft/Flexible 7 7
Device-Device Incompatibility 6 6
Inflation Problem 6 6
Failure to Deflate 5 5
Packaging Problem 5 5
Leak/Splash 4 4
Peeled/Delaminated 4 4
Wrong Label 4 4
Flaked 3 3
Device Dislodged or Dislocated 3 3
Product Quality Problem 3 3
Material Rupture 3 3
Material Integrity Problem 3 3
Unsealed Device Packaging 3 3
Collapse 3 3
Contamination /Decontamination Problem 2 2
Failure to Advance 2 2
Entrapment of Device 2 2
Material Split, Cut or Torn 2 2
Unintended Ejection 1 1
Material Fragmentation 1 1
Air/Gas in Device 1 1
Difficult or Delayed Positioning 1 1
Delivered as Unsterile Product 1 1
Expiration Date Error 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
Material Puncture/Hole 1 1
Malposition of Device 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 740 740
Intracranial Hemorrhage 55 55
Ischemia Stroke 39 39
Vasoconstriction 27 27
Vascular Dissection 27 28
Headache 23 23
Obstruction/Occlusion 21 21
Thromboembolism 21 21
Hemorrhage/Bleeding 17 17
Embolism/Embolus 16 16
Stroke/CVA 15 16
Hematoma 15 15
Swelling/ Edema 14 14
Ischemia 14 14
Foreign Body In Patient 12 12
Hemorrhagic Stroke 12 12
Pain 10 10
Aneurysm 10 10
Perforation of Vessels 9 9
Visual Disturbances 9 9
Bacterial Infection 9 9
Dysphasia 7 7
Fistula 7 7
Thrombosis/Thrombus 7 7
Ruptured Aneurysm 6 6
Paresis 6 6
Rupture 5 5
Transient Ischemic Attack 5 5
Confusion/ Disorientation 5 5
Unspecified Nervous System Problem 5 5
Insufficient Information 5 5
Stenosis 5 5
Respiratory Insufficiency 4 4
Muscle Weakness 4 4
Blurred Vision 4 4
Cerebral Edema 4 4
Paralysis 4 4
Bruise/Contusion 4 4
Nausea 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Inflammation 3 3
Cardiac Arrest 3 3
Skin Discoloration 3 3
Pseudoaneurysm 3 3
Fever 3 3
Dizziness 3 3
Low Blood Pressure/ Hypotension 2 2
Vitreous Floaters 2 2
Respiratory Failure 2 2
Nervous System Injury 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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