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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 6
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 5
BEND IT TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CERUS ENDOVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 3
MARBLEHEAD MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC., D/B/A TERUMO NEURO
  SUBSTANTIALLY EQUIVALENT 1
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
SONOROUS NV, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 7
SUZHOU ZENITH VASCULAR SCITECH LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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 30 30
2022 30 30
2023 75 76
2024 130 130
2025 699 699
2026 486 487

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 726 726
Adverse Event Without Identified Device or Use Problem 231 233
Retraction Problem 171 171
Material Twisted/Bent 103 103
Crack 85 85
Difficult to Advance 75 75
Material Deformation 72 72
Break 66 66
Material Separation 35 35
Unintended Movement 33 33
Burst Container or Vessel 27 27
No Apparent Adverse Event 24 24
Fluid/Blood Leak 23 23
Deformation Due to Compressive Stress 22 22
Stretched 21 21
Difficult to Remove 20 20
Fracture 18 18
Deflation Problem 13 13
Device Damaged by Another Device 11 11
Insufficient Device Problem Information 9 9
Material Too Soft/Flexible 8 8
Packaging Problem 8 8
Inflation Problem 8 8
Material Integrity Problem 8 8
Device-Device Incompatibility 7 7
Failure to Advance 6 6
Peeled/Delaminated 6 6
Leak/Splash 6 6
Collapse 5 5
Product Quality Problem 5 5
Device Dislodged or Dislocated 5 5
Failure to Deflate 5 5
Unsealed Device Packaging 4 4
Wrong Label 4 4
Material Split, Cut or Torn 4 4
Contamination /Decontamination Problem 3 3
Material Puncture/Hole 3 3
Material Rupture 3 3
Compatibility Problem 3 3
Flaked 3 3
Component or Accessory Incompatibility 3 3
Material Fragmentation 2 2
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 2 2
Entrapment of Device 2 2
Air/Gas in Device 1 1
Expiration Date Error 1 1
Unraveled Material 1 1
Defective Component 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1176 1176
Intracranial Hemorrhage 71 72
Ischemia Stroke 56 57
Obstruction/Occlusion 34 35
Vascular Dissection 33 34
Vasoconstriction 30 30
Headache 29 29
Thromboembolism 27 27
Hemorrhage/Blood Loss/Bleeding 23 23
Hematoma 21 21
Embolism/Embolus 20 20
Hemorrhagic Stroke 17 18
Swelling/ Edema 17 17
Foreign Body In Patient 16 16
Ischemia 15 15
Aneurysm 15 15
Stroke/CVA 15 16
Pain 13 13
Unspecified Nervous System Problem 13 13
Bacterial Infection 12 12
Nervous System Injury 11 11
Perforation of Vessels 11 11
Ruptured Aneurysm 11 12
Cerebral Edema 10 11
Transient Ischemic Attack 10 10
Visual Disturbances 10 10
Stenosis 10 10
Dysphasia 8 8
Rupture 8 8
Paresis 8 8
Perforation 8 8
Thrombosis/Thrombus 8 8
Insufficient Information 7 7
Bruise/Contusion 7 7
Fistula 7 7
Foreign Body Reaction 6 6
Confusion/ Disorientation 6 6
Diplopia/Double Vision 6 6
Blurred Vision 5 5
Skin Discoloration 5 5
Paralysis 5 5
Muscle Weakness/Atrophy 5 5
Nausea 5 5
Low Blood Pressure/ Hypotension 4 4
Inflammation 4 4
Cardiac Arrest 4 4
Respiratory Insufficiency 4 4
Pseudoaneurysm 4 4
Speech Disorder 4 4
Hydrocephalus 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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