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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
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 2
BEND IT TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS INC.
  SUBSTANTIALLY EQUIVALENT 1
CERENOVUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
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 3
PERFUZE LTD.
  SUBSTANTIALLY EQUIVALENT 3
Q'APEL MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
Q'APEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
SCIENTIA VASCULAR INC
  SUBSTANTIALLY EQUIVALENT 1
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 3
WALLABY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 16 16
2021 26 26
2022 29 29
2023 71 71
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 46 46
Crack 38 38
Material Separation 30 30
Break 21 21
Fluid/Blood Leak 13 13
Physical Resistance/Sticking 12 12
Material Twisted/Bent 10 10
Deflation Problem 10 10
Difficult to Advance 9 9
Insufficient Information 6 6
Burst Container or Vessel 6 6
Difficult to Remove 6 6
Material Deformation 5 5
Deformation Due to Compressive Stress 5 5
Stretched 3 3
Flaked 3 3
Entrapment of Device 2 2
Unsealed Device Packaging 2 2
Fracture 2 2
Failure to Advance 2 2
Material Too Soft/Flexible 2 2
Material Split, Cut or Torn 2 2
Separation Problem 2 2
Failure to Deflate 2 2
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Delivered as Unsterile Product 1 1
Difficult or Delayed Positioning 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Defective Component 1 1
Retraction Problem 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 133
Intracranial Hemorrhage 14 14
Vascular Dissection 12 12
Vasoconstriction 9 9
Stroke/CVA 7 7
No Consequences Or Impact To Patient 7 7
Hemorrhage/Bleeding 6 6
Foreign Body In Patient 5 5
Perforation of Vessels 5 5
Ischemia Stroke 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Obstruction/Occlusion 3 3
Pain 2 2
Paresis 2 2
Fistula 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Device Embedded In Tissue or Plaque 1 1
Cerebral Edema 1 1
Unspecified Nervous System Problem 1 1
Breast Discomfort/Pain 1 1
Implant Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Transient Ischemic Attack 1 1
Dysphasia 1 1
Thromboembolism 1 1
Rupture 1 1
Stenosis 1 1
Urinary Frequency 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 May-28-2024
4 Stryker, Inc. II Feb-14-2024
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