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
Air/Gas in Device	2981	2986
Adverse Event Without Identified Device or Use Problem	2942	2988
Leak/Splash	1858	1861
Material Twisted/Bent	534	534
Material Integrity Problem	454	454
Gas/Air Leak	449	449
Device Contamination with Body Fluid	388	390
Fluid/Blood Leak	302	302
Nonstandard Device	289	289
Difficult to Advance	214	214
Deformation Due to Compressive Stress	177	178
Suction Problem	136	136
Break	128	128
Difficult to Insert	122	123
Failure to Advance	107	107
Compatibility Problem	99	99
Positioning Failure	96	96
Unintended Movement	96	96
Difficult to Remove	93	93
Material Split, Cut or Torn	81	81
Difficult to Flush	74	74
Device-Device Incompatibility	73	73
Material Deformation	73	73
Improper or Incorrect Procedure or Method	72	72
Use of Device Problem	65	65
Crack	63	63
Device Contamination with Chemical or Other Material	63	63
Difficult or Delayed Positioning	55	55
Device Handling Problem	45	45
Off-Label Use	42	43
Mechanical Problem	38	38
Detachment of Device or Device Component	38	38
Physical Resistance/Sticking	37	37
Peeled/Delaminated	35	35
Positioning Problem	33	33
Noise, Audible	32	32
Product Quality Problem	29	29
Unstable	28	28
Contamination	27	27
Material Separation	25	25
Material Perforation	20	20
Improper Flow or Infusion	20	20
Entrapment of Device	16	16
Tear, Rip or Hole in Device Packaging	14	14
Device Dislodged or Dislocated	13	13
Delivered as Unsterile Product	13	13
Packaging Problem	12	12
No Apparent Adverse Event	11	11
Insufficient Information	11	11
Mechanics Altered	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6269	6276
Pericardial Effusion	654	656
Low Blood Pressure/ Hypotension	641	644
Perforation	479	519
Cardiac Tamponade	430	431
Air Embolism	328	328
Thrombosis/Thrombus	322	323
Non specific EKG/ECG Changes	290	291
Hemorrhage/Bleeding	272	272
No Consequences Or Impact To Patient	180	180
Cardiac Perforation	175	175
Hematoma	167	167
Stroke/CVA	136	136
Cardiac Arrest	135	135
Atrial Perforation	133	133
Pseudoaneurysm	98	98
Hypoxia	90	90
Fistula	87	87
Unspecified Tissue Injury	86	86
No Patient Involvement	80	80
No Known Impact Or Consequence To Patient	79	79
Perforation of Vessels	74	74
Tachycardia	70	70
Bradycardia	59	59
Arrhythmia	57	57
Thrombosis	49	49
Insufficient Information	47	47
Embolism/Embolus	40	40
Vascular Dissection	37	38
Cardiovascular Insufficiency	37	37
Heart Failure/Congestive Heart Failure	35	35
Dyspnea	34	34
Pain	33	34
Ventricular Fibrillation	32	32
Heart Block	31	31
Chest Pain	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Transient Ischemic Attack	27	27
Myocardial Infarction	27	27
Atrial Flutter	26	26
High Blood Pressure/ Hypertension	26	26
Atrial Fibrillation	25	25
Ischemia Stroke	20	20
Syncope/Fainting	19	19
ST Segment Elevation	18	18
Swelling/ Edema	17	17
Paralysis	17	17
Inflammation	17	17
Death	17	17
Muscle Weakness	16	16

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