TPLC - Total Product Life Cycle

• Device: catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Definition: For the treatment of atrial fibrillation.
• Product Code: OAE
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
31	26	43	32	20	16

MDR Year	MDR Reports	MDR Events
2021	914	918
2022	1161	1163
2023	1311	1313
2024	2098	2103
2025	1432	1432
2026	585	585

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2525	2532
Patient Device Interaction Problem	893	894
Device Contamination with Body Fluid	570	570
Material Twisted/Bent	540	540
Optical Problem	427	427
Material Integrity Problem	407	408
Protective Measures Problem	343	343
Communication or Transmission Problem	290	290
Incorrect, Inadequate or Imprecise Result or Readings	287	287
Fracture	234	234
Coagulation in Device or Device Ingredient	203	203
Insufficient Cooling	148	149
Contamination /Decontamination Problem	135	135
Fluid/Blood Leak	124	124
Temperature Problem	121	122
Obstruction of Flow	116	116
Excessive Cooling	109	109
Mechanical Problem	106	106
Material Deformation	104	104
Improper Flow or Infusion	98	99
Signal Artifact/Noise	97	97
Use of Device Problem	91	91
Failure to Sense	78	78
Electrical Shorting	72	72
Display or Visual Feedback Problem	67	67
Compatibility Problem	66	66
Gas/Air Leak	63	63
Leak/Splash	58	58
Infusion or Flow Problem	57	57
Overheating of Device	55	55
No Apparent Adverse Event	50	50
High impedance	41	41
Off-Label Use	37	38
Increase in Pressure	36	36
Device Handling Problem	35	35
Insufficient Device Problem Information	35	35
Impedance Problem	33	33
Material Separation	31	31
Appropriate Device Problem Term/Code Not Available	29	29
Device Sensing Problem	25	25
Device Displays Incorrect Message	25	25
Device Contamination with Chemical or Other Material	25	26
Improper or Incorrect Procedure or Method	24	24
Entrapment of Device	19	19
Failure to Pump	18	19
Restricted Flow rate	17	17
Activation, Positioning or Separation Problem	16	16
Connection Problem	16	16
Failure to Deliver Energy	15	15
High Readings	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4022	4027
Cardiac Perforation	940	942
Cardiac Tamponade	652	653
Nerve Damage	507	507
Pericardial Effusion	319	319
Stroke/CVA	249	250
Low Blood Pressure/ Hypotension	226	226
Heart Block	177	177
Cardiac Arrest	106	106
Arrhythmia	102	102
Thrombosis/Thrombus	93	93
Pericarditis	93	94
Hemorrhage/Blood Loss/Bleeding	80	81
Fistula	79	79
Tachycardia	77	77
Insufficient Information	73	73
Stenosis	70	70
Atrial Fibrillation	64	64
Chest Pain	64	64
Non specific EKG/ECG Changes	54	55
Perforation of Esophagus	48	48
Atrial Flutter	46	46
Heart Failure/Congestive Heart Failure	44	44
Transient Ischemic Attack	43	43
Air Embolism	40	40
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	40	40
Dyspnea	36	36
Hematoma	35	36
Ventricular Fibrillation	35	35
Pseudoaneurysm	34	35
Embolism/Embolus	33	33
Paralysis	32	32
Perforation	31	31
Vascular Dissection	29	29
Bradycardia	29	29
Paresis	24	24
Inflammation	24	24
Pleural Effusion	23	23
Unspecified Tissue Injury	22	22
Pain	22	22
Hemoptysis	21	21
Ischemia Stroke	19	19
Hypoxia	18	18
Fever	15	15
Unspecified Nervous System Problem	15	15
Pulmonary Edema	15	15
Vomiting	15	15
Foreign Body In Patient	14	14
Cardiovascular Dysfunction/Insufficiency	13	13
Nausea	13	13

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott	I	Oct-10-2025
2	Abbott	II	Jul-07-2022
3	Abbott	II	Apr-19-2022
4	Boston Scientific Corporation	I	Nov-12-2024
5	CardioFocus, Inc.	II	Mar-10-2025
6	EPIX THERAPEUTICS, INC	II	Mar-29-2021
7	St. Jude Medical, Atrial Fibrillation Division, Inc.	II	Jan-25-2024