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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)
Regulation Description Ventricular catheter.
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
2016 5 5
2017 7 7
2018 5 5
2019 2 2
2020 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9 9
Fluid Leak 8 8
Fracture 4 4
Difficult to Remove 2 2
Material Split, Cut or Torn 2 2
Material Separation 1 1
Detachment of Device or Device Component 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Appropriate Term/Code Not Available 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 7 7
Device Embedded In Tissue or Plaque 5 5
Cerebrospinal Fluid Leakage 1 1
Unspecified Infection 1 1
Therapeutic Effects, Unexpected 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Aug-12-2018
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