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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

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
Physical Resistance/Sticking 5 5
Mechanical Problem 4 4
Detachment of Device or Device Component 2 2
Mechanics Altered 2 2
Failure to Obtain Sample 2 2
Mechanical Jam 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation Failure 2 2
Fracture 2 2
Difficult to Remove 2 2
Corroded 1 1
Defective Component 1 1
Component Missing 1 1
Protective Measures Problem 1 1
Malposition of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Output Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
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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