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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, intraspinal, short term
Regulation Description Anesthesia conduction catheter.
Product CodeMAJ
Regulation Number 868.5120
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 3
2022 4 4
2023 8 8
2024 4 4
2025 18 18
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 27 27
Fracture 20 20
Adverse Event Without Identified Device or Use Problem 17 17
Insufficient Information 6 6
Activation, Positioning or Separation Problem 1 1
Difficult to Advance 1 1
Difficult to Insert 1 1
Obstruction of Flow 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
Hemorrhage/Bleeding 18 18
Perforation of Vessels 16 16
Device Embedded In Tissue or Plaque 4 4
Failure of Implant 2 2
Foreign Body In Patient 2 2
Hematoma 1 1
Unspecified Tissue Injury 1 1
Great Vessel Perforation 1 1
Low Blood Pressure/ Hypotension 1 1

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