TPLC - Total Product Life Cycle

• Device: low energy direct current thermal ablation system
• Definition: Ablation of soft tissue
• Product Code: OAB
• Regulation Number: 878.4400
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ANGIODYNAMICS
	SUBSTANTIALLY EQUIVALENT	1
GALVANIZE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	23	23
Communication or Transmission Problem	7	7
Failure of Device to Self-Test	2	2
Arcing of Electrodes	2	2
Melted	2	2
Failure to Fire	2	2
Charging Problem	2	2
Computer Software Problem	2	2
Material Discolored	2	2
Failure to Deliver Energy	2	2
Energy Output Problem	2	2
Device Remains Activated	2	2
Unexpected Shutdown	2	2
Firing Problem	2	2
Output Problem	2	2
Packaging Problem	1	1
Power Problem	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
Wireless Communication Problem	1	1
Migration	1	1
Component Misassembled	1	1
Material Too Soft/Flexible	1	1
Complete Loss of Power	1	1
Intermittent Loss of Power	1	1
Unintended Electrical Shock	1	1
No Visual Prompts/Feedback	1	1
Intermittent Energy Output	1	1
Output below Specifications	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
Output above Specifications	1	1
Pacing Problem	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
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
No Display/Image	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
Contamination /Decontamination Problem	1	1
Battery Problem	1	1
Calibration Problem	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
Arcing	1	1
Delayed Charge Time	1	1
Device Displays Incorrect Message	1	1
Sparking	1	1
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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	9	9
No Clinical Signs, Symptoms or Conditions	6	6
Thrombosis/Thrombus	4	4
Patient Problem/Medical Problem	4	4
Tissue Breakdown	3	3
Obstruction/Occlusion	2	2
Atrial Fibrillation	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
Bacterial Infection	1	1
Burn(s)	1	1
Fistula	1	1
Hemorrhage/Bleeding	1	1
Necrosis	1	1
Pain	1	1
Paresis	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	Oct-07-2021