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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
Product CodeDWZ
Regulation Number 870.4075
Device Class 2

MDR Year MDR Reports MDR Events
2018 7 7
2019 5 5
2020 5 5
2021 5 5
2022 14 14
2023 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Difficult to Open or Close 7 7
Break 7 7
Mechanical Problem 5 5
Physical Resistance/Sticking 5 5
Therapeutic or Diagnostic Output Failure 2 2
Activation Failure 2 2
Difficult to Remove 2 2
Failure to Obtain Sample 2 2
Fracture 2 2
Detachment of Device or Device Component 2 2
Mechanical Jam 2 2
Mechanics Altered 2 2
Output Problem 1 1
Protective Measures Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Defective Device 1 1
Malposition of Device 1 1
Corroded 1 1
Defective Component 1 1
Component Missing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15 15
Insufficient Information 7 7
No Known Impact Or Consequence To Patient 6 6
Cardiac Tamponade 6 6
Cardiac Perforation 4 4
Perforation of Vessels 3 3
No Consequences Or Impact To Patient 3 3
Tachycardia 2 2
No Code Available 2 2
Pericardial Effusion 2 2
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Unspecified Tissue Injury 1 1
Arrhythmia 1 1
Ventricular Fibrillation 1 1
Foreign Body In Patient 1 1
Discomfort 1 1

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