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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ventricular (containing antibiotic or antimicrobial agents)
Definition Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Product CodeNHC
Regulation Number 882.4100
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 3 3
2016 5 5
2017 7 7
2018 5 5
2019 2 2
2020 9 9
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Fluid/Blood Leak 8 8
Fracture 4 4
Difficult to Remove 2 2
Material Separation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 2 2
Insufficient Information 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Hole In Material 1 1
Flaked 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 12 12
No Code Available 8 8
Device Embedded In Tissue or Plaque 5 5
Death 2 2
Unspecified Infection 2 2
Therapeutic Effects, Unexpected 1 1
Therapeutic Response, Decreased 1 1
Meningitis 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
Hemorrhage, Cerebral 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cerebrospinal Fluid Leakage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Aug-12-2018
2 Cook Inc. II Dec-14-2015
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