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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device low energy direct current thermal ablation system
Definition Ablation of soft tissue
Product CodeOAB
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS
  SUBSTANTIALLY EQUIVALENT 1
GALVANIZE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 6 6
2020 16 16
2021 11 11
2022 4 4
2023 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 26
Communication or Transmission Problem 7 7
Arcing of Electrodes 4 4
Device Remains Activated 3 3
Unexpected Shutdown 3 3
Output Problem 2 2
Charging Problem 2 2
Firing Problem 2 2
Power Problem 2 2
Pacing Problem 2 2
Computer Software Problem 2 2
Material Discolored 2 2
No Display/Image 2 2
Failure to Deliver Energy 2 2
Melted 2 2
Energy Output Problem 2 2
Failure to Fire 2 2
Device Sensing Problem 2 2
Failure of Device to Self-Test 2 2
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
No Flow 1 1
Difficult to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Expulsion 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Battery Problem 1 1
Calibration Problem 1 1
Output above Specifications 1 1
Migration or Expulsion of Device 1 1
Poor Quality Image 1 1
Delivered as Unsterile Product 1 1
Material Opacification 1 1
Incomplete or Missing Packaging 1 1
Failure to Deliver 1 1
Failure to Infuse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Failure to Calibrate 1 1
Failure to Advance 1 1
Misfire 1 1
Low Sensing Threshold 1 1
Arcing 1 1
Delayed Charge Time 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Flaked 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inability to Irrigate 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Display or Visual Feedback Problem 1 1
Continuous Firing 1 1
Crack 1 1
Arcing at Paddles 1 1
Loss of or Failure to Bond 1 1
Break 1 1
Failure to Charge 1 1
Unsealed Device Packaging 1 1
Pitted 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Decreased Pump Speed 1 1
Increased Pump Speed 1 1
Failure to Pump 1 1
Pumping Stopped 1 1
Material Puncture/Hole 1 1
Difficult to Remove 1 1
Shipping Damage or Problem 1 1
Device Stops Intermittently 1 1
Stretched 1 1
Inaccurate Synchronization 1 1
Unexpected Therapeutic Results 1 1
Use of Device Problem 1 1
Insufficient Flow or Under Infusion 1 1
Material Perforation 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Aborted Charge 1 1
Pumping Problem 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 9 9
Thrombosis/Thrombus 5 5
Patient Problem/Medical Problem 4 4
Tissue Breakdown 3 3
Obstruction/Occlusion 2 2
Atrial Fibrillation 2 2
Fistula 2 2
Tachycardia 2 2
No Consequences Or Impact To Patient 2 2
Ulcer 1 1
Aneurysm 1 1
Arrhythmia 1 1
Tissue Damage 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Hemorrhage/Bleeding 1 1
Necrosis 1 1
Internal Organ Perforation 1 1
Pain 1 1
Paresis 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Burn(s) 1 1
Fluid Discharge 1 1
Heart Failure/Congestive Heart Failure 1 1
Movement Disorder 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Apr-12-2023
2 Angiodynamics, Inc. II Oct-07-2021
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