TPLC - Total Product Life Cycle

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Device	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Definition	For the treatment of atrial flutter.
Product Code	OAD
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
50	20	19	19	19	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	361	362
Material Integrity Problem	213	213
Patient Device Interaction Problem	211	212
Fluid/Blood Leak	136	136
Temperature Problem	104	104
Device Displays Incorrect Message	70	70
Obstruction of Flow	54	54
Signal Artifact/Noise	40	40
Defective Device	39	39
Communication or Transmission Problem	36	36
Leak/Splash	33	33
Improper Flow or Infusion	31	31
Positioning Problem	31	31
Fracture	29	29
Insufficient Cooling	26	26
Device Contamination with Chemical or Other Material	23	23
Impedance Problem	20	20
Nonstandard Device	20	20
Poor Quality Image	17	17
Break	17	18
Failure to Deliver Energy	16	16
Insufficient Flow or Under Infusion	14	14
Detachment of Device or Device Component	14	14
Improper or Incorrect Procedure or Method	13	13
Material Perforation	12	12
Tear, Rip or Hole in Device Packaging	12	12
Mechanical Jam	12	12
Pressure Problem	12	12
Material Twisted/Bent	11	11
Activation, Positioning or Separation Problem	11	11
Material Deformation	10	10
Contamination	10	10
Device Contamination with Body Fluid	10	10
Noise, Audible	10	10
Failure to Sense	9	9
Material Protrusion/Extrusion	9	9
Incorrect, Inadequate or Imprecise Result or Readings	9	9
No Apparent Adverse Event	9	9
High impedance	9	9
Overheating of Device	9	9
Thermal Decomposition of Device	8	8
Output Problem	8	8
Electrical Shorting	7	7
Display or Visual Feedback Problem	7	7
Insufficient Device Problem Information	7	7
Excessive Heating	7	7
Device Remains Activated	6	6
Insufficient Heating	6	6
Output below Specifications	6	6
Data Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1032	1034
Cardiac Perforation	155	155
Cardiac Tamponade	141	142
Heart Block	68	69
Pericardial Effusion	53	53
Stroke/CVA	52	52
Arrhythmia	33	33
Insufficient Information	27	27
Cardiac Arrest	23	23
Nerve Damage	23	23
Thrombosis/Thrombus	22	22
Low Blood Pressure/ Hypotension	22	22
Tachycardia	17	17
Pericarditis	17	17
Hematoma	16	16
Stenosis	14	14
Fistula	14	14
Transient Ischemic Attack	14	14
Air Embolism	14	14
Chest Pain	13	13
Vascular Dissection	11	11
Hemorrhage/Blood Loss/Bleeding	10	10
Paralysis	10	10
Pseudoaneurysm	10	10
Perforation of Esophagus	9	10
Ventricular Fibrillation	8	8
Embolism/Embolus	8	8
Ischemia Stroke	8	8
Dyspnea	7	7
No Consequences Or Impact To Patient	7	7
Atrial Fibrillation	7	7
Bradycardia	6	6
Pulmonary Embolism	6	6
Vasoconstriction	5	5
Non specific EKG/ECG Changes	5	5
Cardiogenic Shock	5	5
Unspecified Tissue Injury	5	5
Partial thickness (Second Degree) Burn	5	5
Headache	5	5
Sepsis	4	5
Syncope/Fainting	4	4
Asystole	4	4
Perforation	4	4
No Known Impact Or Consequence To Patient	4	4
Retroperitoneal Hemorrhage	4	4
Pain	4	4
Heart Failure/Congestive Heart Failure	3	3
Electric Shock	3	3
Unspecified Vascular Problem	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Johnson & Johnson Surgical Vision, Inc.	II	Nov-02-2022
2	Medtronic, Inc.	II	Apr-24-2026