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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
  1.  K213589  FUBUKI XF Neurovascular Long Sheath
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213589  FUBUKI XF Neurovascular Long Sheath
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
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 1
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 5
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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 59 59
Crack 51 51
Material Separation 31 31
Break 23 23
Material Twisted/Bent 21 21
Difficult to Advance 15 15
Fluid/Blood Leak 15 15
Physical Resistance/Sticking 13 13
Deflation Problem 10 10
Material Deformation 8 8
Fracture 7 7
Burst Container or Vessel 7 7
Insufficient Information 6 6
Difficult to Remove 6 6
Deformation Due to Compressive Stress 5 5
Device-Device Incompatibility 4 4
Stretched 4 4
Device Damaged by Another Device 4 4
Flaked 3 3
Unsealed Device Packaging 3 3
Material Too Soft/Flexible 3 3
Inflation Problem 3 3
Failure to Deflate 3 3
Failure to Advance 2 2
Entrapment of Device 2 2
Peeled/Delaminated 2 2
Separation Problem 2 2
Wrong Label 2 2
Material Split, Cut or Torn 2 2
Component or Accessory Incompatibility 1 1
Delivered as Unsterile Product 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Material Fragmentation 1 1
Contamination /Decontamination Problem 1 1
Air/Gas in Device 1 1
Detachment of Device or Device Component 1 1
Defective Component 1 1
Material Rupture 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 171 171
Intracranial Hemorrhage 17 17
Vascular Dissection 15 15
Vasoconstriction 13 13
Stroke/CVA 10 10
No Consequences Or Impact To Patient 7 7
Perforation of Vessels 6 6
Hemorrhage/Bleeding 6 6
Foreign Body In Patient 5 5
Ischemia Stroke 5 5
Thromboembolism 4 4
Fistula 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Obstruction/Occlusion 3 3
Pain 2 2
Paresis 2 2
Cardiac Arrest 2 2
Swelling/ Edema 2 2
Transient Ischemic Attack 1 1
Dysphasia 1 1
Rupture 1 1
Hypersensitivity/Allergic reaction 1 1
Implant Pain 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
Breast Discomfort/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 Stryker Neurovascular II Oct-07-2024
4 Stryker Neurovascular II May-28-2024
5 Stryker, Inc. II Feb-14-2024
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