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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


Premarket Reviews
ManufacturerDecision
FEHLING INSTRUMENTS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 4 4
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 14 14
Difficult to Open or Close 7 7
Break 7 7
Mechanical Problem 5 5
Physical Resistance/Sticking 5 5
Mechanical Jam 3 3
Difficult to Remove 3 3
Failure to Obtain Sample 2 2
Detachment of Device or Device Component 2 2
Mechanics Altered 2 2
Therapeutic or Diagnostic Output Failure 2 2
Fracture 2 2
Activation Failure 2 2
Insufficient Information 1 1
Device Operates Differently Than Expected 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Output Problem 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Defective Device 1 1
Malposition of Device 1 1
Corroded 1 1
Sticking 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 7 7
Cardiac Tamponade 6 6
Cardiac Perforation 4 4
No Consequences Or Impact To Patient 4 4
Pericardial Effusion 3 3
Perforation of Vessels 3 3
Tachycardia 2 2
No Code Available 2 2
Ventricular Fibrillation 1 1
Vessel Or Plaque, Device Embedded In 1 1
Arrhythmia 1 1
Great Vessel Perforation 1 1
Discomfort 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Unspecified Tissue Injury 1 1
Foreign Body In Patient 1 1
No Information 1 1

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