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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
AQURE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPERATIVE CARE INC.
  SUBSTANTIALLY EQUIVALENT 2
MARBLEHEAD MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MARBLEHEAD MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  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 1
SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
STRYKER NEUROVASCULAR
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 16 16
2021 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 9 9
Fluid Leak 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Physical Resistance/Sticking 5 5
Break 3 3
Material Deformation 3 3
Material Twisted/Bent 3 3
Failure to Advance 2 2
Fracture 2 2
Deflation Problem 2 2
Separation Problem 2 2
Material Separation 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 7 7
Vascular Dissection 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Ischemia Stroke 1 1
Breast Discomfort/Pain 1 1
Implant Pain 1 1
Urinary Frequency 1 1
Stroke/CVA 1 1
Hemorrhage/Bleeding 1 1
Pain 1 1

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