TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ACUTUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC CRYOCATH LP
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1813	1852
Leak/Splash	1095	1095
Air/Gas in Device	676	676
Material Twisted/Bent	295	295
Gas/Air Leak	268	268
Material Integrity Problem	212	212
Device Contamination with Body Fluid	126	126
Deformation Due to Compressive Stress	123	123
Break	96	96
Failure to Advance	85	85
Compatibility Problem	73	73
Material Split, Cut or Torn	73	73
Positioning Failure	72	72
Unintended Movement	71	71
Difficult to Insert	70	70
Difficult to Remove	62	62
Material Deformation	54	54
Difficult to Advance	52	52
Fluid/Blood Leak	51	51
Improper or Incorrect Procedure or Method	50	50
Difficult or Delayed Positioning	48	48
Use of Device Problem	39	39
Crack	38	38
Suction Problem	33	33
Off-Label Use	30	30
Difficult to Flush	28	28
Device Contamination with Chemical or Other Material	26	26
Device Handling Problem	24	24
Unstable	24	24
Peeled/Delaminated	24	24
Physical Resistance/Sticking	23	23
Noise, Audible	23	23
Material Separation	21	21
Product Quality Problem	21	21
Device-Device Incompatibility	19	19
Detachment of Device or Device Component	18	18
Mechanical Problem	15	15
Entrapment of Device	14	14
Tear, Rip or Hole in Device Packaging	10	10
Positioning Problem	9	9
Packaging Problem	8	8
Signal Artifact/Noise	8	8
Mechanical Jam	6	6
Insufficient Information	6	6
Device Markings/Labelling Problem	6	6
Improper Flow or Infusion	6	6
Appropriate Term/Code Not Available	6	6
Loose or Intermittent Connection	5	5
Activation, Positioning or Separation Problem	5	5
Flushing Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2455	2455
Pericardial Effusion	398	398
Low Blood Pressure/ Hypotension	368	368
Perforation	353	392
Cardiac Tamponade	292	292
Thrombosis/Thrombus	201	201
Air Embolism	181	181
No Consequences Or Impact To Patient	180	180
Hemorrhage/Bleeding	160	160
Non specific EKG/ECG Changes	134	134
Atrial Perforation	133	133
Hematoma	114	114
Cardiac Perforation	105	105
No Patient Involvement	80	80
No Known Impact Or Consequence To Patient	79	79
Cardiac Arrest	74	74
Pseudoaneurysm	71	71
Stroke/CVA	70	70
Fistula	63	63
Hypoxia	63	63
Unspecified Tissue Injury	55	55
Thrombosis	49	49
Tachycardia	42	42
Perforation of Vessels	39	39
Insufficient Information	39	39
Arrhythmia	37	37
Cardiovascular Insufficiency	36	36
Embolism/Embolus	29	29
Bradycardia	28	28
Chest Pain	23	23
Heart Failure/Congestive Heart Failure	21	21
Pain	21	21
Transient Ischemic Attack	20	20
Atrial Flutter	18	18
ST Segment Elevation	18	18
Dyspnea	18	18
High Blood Pressure/ Hypertension	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Ventricular Fibrillation	17	17
Death	17	17
Vascular Dissection	16	16
Heart Block	16	16
Atrial Fibrillation	16	16
Embolism	16	16
Inflammation	15	15
Myocardial Infarction	15	15
Cardiogenic Shock	13	13
Heart Failure	12	12
Respiratory Distress	12	12
Paralysis	11	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Mar-26-2024
2	Medtronic Perfusion Systems	II	Sep-22-2021