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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
KANEKA AMERICAS HOLDING, INC.
  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
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
2020 16 16
2021 29 29
2022 30 30
2023 75 76
2024 129 129
2025 696 696
2026 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 531 531
Adverse Event Without Identified Device or Use Problem 187 188
Retraction Problem 77 77
Crack 76 76
Material Twisted/Bent 67 67
Material Deformation 52 52
Break 50 50
Difficult to Advance 49 49
Material Separation 34 34
Fluid/Blood Leak 22 22
Burst Container or Vessel 21 21
Unintended Movement 20 20
Stretched 19 19
No Apparent Adverse Event 17 17
Deformation Due to Compressive Stress 16 16
Fracture 15 15
Deflation Problem 13 13
Difficult to Remove 13 13
Device Damaged by Another Device 10 10
Insufficient Information 9 9
Material Too Soft/Flexible 7 7
Inflation Problem 7 7
Device-Device Incompatibility 6 6
Failure to Deflate 5 5
Peeled/Delaminated 5 5
Packaging Problem 5 5
Product Quality Problem 4 4
Wrong Label 4 4
Leak/Splash 4 4
Material Integrity Problem 3 3
Unsealed Device Packaging 3 3
Material Rupture 3 3
Collapse 3 3
Failure to Advance 3 3
Device Dislodged or Dislocated 3 3
Flaked 3 3
Contamination /Decontamination Problem 2 2
Patient-Device Incompatibility 2 2
Entrapment of Device 2 2
Separation Problem 2 2
Material Split, Cut or Torn 2 2
Air/Gas in Device 1 1
Material Fragmentation 1 1
Expiration Date Error 1 1
Unintended Ejection 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Difficult or Delayed Positioning 1 1
Delivered as Unsterile Product 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 857 857
Intracranial Hemorrhage 56 56
Ischemia Stroke 43 43
Vasoconstriction 28 28
Vascular Dissection 27 28
Headache 26 26
Obstruction/Occlusion 23 23
Thromboembolism 21 21
Hemorrhage/Bleeding 19 19
Stroke/CVA 16 17
Swelling/ Edema 16 16
Embolism/Embolus 16 16
Hematoma 15 15
Ischemia 14 14
Foreign Body In Patient 13 13
Hemorrhagic Stroke 13 13
Bacterial Infection 11 11
Pain 11 11
Aneurysm 10 10
Visual Disturbances 10 10
Perforation of Vessels 9 9
Bruise/Contusion 7 7
Fistula 7 7
No Consequences Or Impact To Patient 7 7
Stenosis 7 7
Thrombosis/Thrombus 7 7
Transient Ischemic Attack 7 7
Dysphasia 7 7
Ruptured Aneurysm 6 6
Insufficient Information 6 6
Paresis 6 6
Rupture 5 5
Unspecified Nervous System Problem 5 5
Nervous System Injury 5 5
Foreign Body Reaction 5 5
Skin Discoloration 5 5
Confusion/ Disorientation 5 5
Blurred Vision 5 5
Cerebral Edema 4 4
Respiratory Insufficiency 4 4
Nausea 4 4
Muscle Weakness 4 4
Paralysis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Pseudoaneurysm 3 3
Vitreous Floaters 3 3
Dizziness 3 3
Fever 3 3
Inflammation 3 3
Cardiac Arrest 3 3

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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