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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, biopsy, endomyocardial
Regulation Description Endomyocardial biopsy device.
Product CodeDWZ
Regulation Number 870.4075
Device Class 2


Premarket Reviews
ManufacturerDecision
FEHLING INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 5 5
2021 5 5
2022 14 14
2023 10 10
2024 4 4
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15 15
Break 6 6
Difficult to Open or Close 5 5
Physical Resistance/Sticking 5 5
Mechanical Problem 4 4
Fracture 2 2
Difficult to Remove 2 2
Failure to Obtain Sample 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation Failure 2 2
Defective Component 1 1
Detachment of Device or Device Component 1 1
Output Problem 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 8 8
Cardiac Tamponade 7 7
No Known Impact Or Consequence To Patient 4 4
Cardiac Perforation 4 4
Perforation of Vessels 3 3
Pericardial Effusion 2 2
Tachycardia 2 2
Unspecified Infection 1 1
Arrhythmia 1 1
Embolism/Embolus 1 1
Ventricular Fibrillation 1 1
Thrombosis/Thrombus 1 1
Discomfort 1 1
Unspecified Tissue Injury 1 1
No Consequences Or Impact To Patient 1 1

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