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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
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
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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 58 58
Crack 48 48
Material Separation 31 31
Break 23 23
Material Twisted/Bent 20 20
Fluid/Blood Leak 15 15
Difficult to Advance 15 15
Physical Resistance/Sticking 13 13
Deflation Problem 10 10
Material Deformation 8 8
Burst Container or Vessel 7 7
Fracture 7 7
Insufficient Information 6 6
Difficult to Remove 6 6
Deformation Due to Compressive Stress 5 5
Device Damaged by Another Device 4 4
Stretched 4 4
Device-Device Incompatibility 3 3
Flaked 3 3
Failure to Deflate 3 3
Material Too Soft/Flexible 3 3
Unsealed Device Packaging 3 3
Inflation Problem 3 3
Failure to Advance 2 2
Wrong Label 2 2
Peeled/Delaminated 2 2
Entrapment of Device 2 2
Separation Problem 2 2
Material Split, Cut or Torn 2 2
Material Fragmentation 1 1
Air/Gas in Device 1 1
Contamination /Decontamination Problem 1 1
Difficult or Delayed Positioning 1 1
Expiration Date Error 1 1
Delivered as Unsterile Product 1 1
Material Rupture 1 1
Defective Component 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
No Apparent Adverse Event 1 1
Unintended Movement 1 1
Malposition of Device 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 168 168
Intracranial Hemorrhage 17 17
Vascular Dissection 15 15
Vasoconstriction 12 12
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Obstruction/Occlusion 3 3
Insufficient Information 3 3
Fistula 3 3
Cardiac Arrest 2 2
Pain 2 2
Paresis 2 2
Swelling/ Edema 2 2
Dysphasia 1 1
Hypersensitivity/Allergic reaction 1 1
Implant Pain 1 1
Rupture 1 1
Transient Ischemic Attack 1 1
Unspecified Nervous System Problem 1 1
Stenosis 1 1
Urinary Frequency 1 1
Breast Discomfort/Pain 1 1
Cerebral Edema 1 1
Device Embedded In Tissue or Plaque 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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