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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 2
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BALT USA, LLC
  SUBSTANTIALLY EQUIVALENT 3
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS INC.
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 4
IMPERATIVE CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
MIVI NEUROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEURAVI LIMITED
  SUBSTANTIALLY EQUIVALENT 2
PENUMBRA, INC
  SUBSTANTIALLY EQUIVALENT 1
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 4
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 4
PIRAEUS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
Q'APEL MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RIST NEUROVASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ROUTE 92 MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
ROUTE 92 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPARTAN MICRO
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 7
UNITY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 26 26
2022 29 29
2023 73 73
2024 114 114
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 66 66
Crack 63 63
Material Separation 34 34
Material Twisted/Bent 24 24
Break 23 23
Fluid/Blood Leak 18 18
Difficult to Advance 16 16
Physical Resistance/Sticking 13 13
Deflation Problem 11 11
Burst Container or Vessel 10 10
Fracture 10 10
Material Deformation 8 8
Insufficient Information 7 7
Deformation Due to Compressive Stress 6 6
Device Damaged by Another Device 6 6
Difficult to Remove 6 6
Stretched 5 5
Material Too Soft/Flexible 4 4
Device-Device Incompatibility 4 4
Wrong Label 3 3
Failure to Deflate 3 3
Peeled/Delaminated 3 3
Unsealed Device Packaging 3 3
Inflation Problem 3 3
Flaked 3 3
Entrapment of Device 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 2 2
Separation Problem 2 2
Failure to Advance 2 2
Defective Component 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Material Fragmentation 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
Unintended Movement 1 1
Component or Accessory Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Malposition of Device 1 1
Expiration Date Error 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 203 203
Intracranial Hemorrhage 17 17
Vascular Dissection 17 17
Vasoconstriction 14 14
Stroke/CVA 10 10
No Consequences Or Impact To Patient 7 7
Hemorrhage/Bleeding 6 6
Perforation of Vessels 6 6
Obstruction/Occlusion 6 6
Ischemia Stroke 6 6
Thromboembolism 5 5
Foreign Body In Patient 5 5
Fistula 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cardiac Arrest 2 2
Pain 2 2
Paresis 2 2
Swelling/ Edema 2 2
Hypersensitivity/Allergic reaction 1 1
Transient Ischemic Attack 1 1
Dysphasia 1 1
Rupture 1 1
Stenosis 1 1
Urinary Frequency 1 1
Device Embedded In Tissue or Plaque 1 1
Cerebral Edema 1 1
Unspecified Nervous System Problem 1 1
Embolism/Embolus 1 1
Breast Discomfort/Pain 1 1
Implant Pain 1 1

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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