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
KARDIUM INC.
	SUBSTANTIALLY EQUIVALENT	1
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	2275	2314
Air/Gas in Device	1615	1615
Leak/Splash	1502	1502
Material Twisted/Bent	442	442
Material Integrity Problem	355	355
Gas/Air Leak	349	349
Device Contamination with Body Fluid	224	224
Deformation Due to Compressive Stress	141	141
Break	116	116
Difficult to Advance	110	110
Failure to Advance	98	98
Compatibility Problem	88	88
Unintended Movement	88	88
Positioning Failure	85	85
Difficult to Insert	82	82
Material Split, Cut or Torn	76	76
Difficult to Remove	75	75
Suction Problem	71	71
Difficult to Flush	66	66
Material Deformation	62	62
Use of Device Problem	60	60
Improper or Incorrect Procedure or Method	57	57
Fluid/Blood Leak	56	56
Crack	56	56
Difficult or Delayed Positioning	49	49
Device-Device Incompatibility	45	45
Device Contamination with Chemical or Other Material	38	38
Off-Label Use	37	37
Device Handling Problem	34	34
Physical Resistance/Sticking	32	32
Peeled/Delaminated	31	31
Noise, Audible	30	30
Detachment of Device or Device Component	28	28
Unstable	27	27
Product Quality Problem	26	26
Material Separation	25	25
Mechanical Problem	25	25
Positioning Problem	19	19
Entrapment of Device	16	16
Improper Flow or Infusion	13	13
Material Perforation	11	11
Tear, Rip or Hole in Device Packaging	11	11
Packaging Problem	10	10
Signal Artifact/Noise	9	9
Flushing Problem	8	8
Insufficient Information	8	8
Mechanical Jam	8	8
Appropriate Term/Code Not Available	7	7
Loose or Intermittent Connection	7	7
Unsealed Device Packaging	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4140	4140
Pericardial Effusion	485	485
Low Blood Pressure/ Hypotension	476	476
Perforation	414	453
Cardiac Tamponade	341	341
Thrombosis/Thrombus	254	254
Air Embolism	245	245
Non specific EKG/ECG Changes	205	205
Hemorrhage/Bleeding	189	189
No Consequences Or Impact To Patient	180	180
Hematoma	133	133
Atrial Perforation	133	133
Cardiac Perforation	127	127
Cardiac Arrest	95	95
Stroke/CVA	90	90
Pseudoaneurysm	81	81
No Patient Involvement	80	80
No Known Impact Or Consequence To Patient	79	79
Fistula	71	71
Hypoxia	69	69
Unspecified Tissue Injury	65	65
Perforation of Vessels	58	58
Tachycardia	51	51
Thrombosis	49	49
Arrhythmia	47	47
Insufficient Information	44	44
Bradycardia	36	36
Cardiovascular Insufficiency	36	36
Embolism/Embolus	34	34
Vascular Dissection	27	27
Heart Failure/Congestive Heart Failure	27	27
Pain	25	25
Ventricular Fibrillation	24	24
Chest Pain	24	24
Dyspnea	24	24
Myocardial Infarction	22	22
Transient Ischemic Attack	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	22	22
Atrial Flutter	20	20
Atrial Fibrillation	19	19
Heart Block	19	19
High Blood Pressure/ Hypertension	18	18
ST Segment Elevation	18	18
Death	17	17
Embolism	16	16
Inflammation	16	16
Paralysis	14	14
Cardiogenic Shock	13	13
Heart Failure	12	12
Respiratory Distress	12	12

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