TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ACUTUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
FREUDENBERG MEDICAL LLC
	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	1927	1966
Leak/Splash	1039	1039
Air/Gas in Device	391	391
Gas/Air Leak	323	323
Material Twisted/Bent	297	297
Material Integrity Problem	140	140
Deformation Due to Compressive Stress	132	132
Break	97	97
Failure to Advance	90	90
Fluid/Blood Leak	81	81
Material Split, Cut or Torn	80	80
Positioning Failure	79	79
Device Contamination with Body Fluid	77	77
Unintended Movement	76	76
Difficult to Insert	75	75
Compatibility Problem	66	66
Improper or Incorrect Procedure or Method	63	63
Difficult to Remove	60	60
Material Deformation	55	55
Difficult or Delayed Positioning	51	51
Difficult to Advance	46	46
Crack	35	35
Use of Device Problem	31	31
Noise, Audible	28	28
Off-Label Use	28	28
Material Separation	27	27
Peeled/Delaminated	25	25
Unstable	22	22
Device Handling Problem	22	22
Device Contamination with Chemical or Other Material	21	21
Product Quality Problem	21	21
Difficult to Flush	21	21
Physical Resistance/Sticking	21	21
Mechanical Problem	15	15
Suction Problem	14	14
Device-Device Incompatibility	13	13
Entrapment of Device	13	13
Detachment of Device or Device Component	12	12
Tear, Rip or Hole in Device Packaging	11	11
Appropriate Term/Code Not Available	9	9
Signal Artifact/Noise	8	8
Mechanical Jam	7	7
Positioning Problem	7	7
Insufficient Information	7	7
Activation, Positioning or Separation Problem	6	6
Device Markings/Labelling Problem	6	6
Device Damaged by Another Device	5	5
Loose or Intermittent Connection	4	4
No Apparent Adverse Event	4	4
Flushing Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1824	1824
Pericardial Effusion	433	433
Low Blood Pressure/ Hypotension	375	375
Perforation	337	376
Cardiac Tamponade	296	296
No Consequences Or Impact To Patient	261	261
No Known Impact Or Consequence To Patient	236	236
Atrial Perforation	215	215
Air Embolism	178	178
Thrombosis/Thrombus	176	176
Hemorrhage/Bleeding	175	175
No Patient Involvement	150	150
Hematoma	142	142
Non specific EKG/ECG Changes	118	118
Cardiac Perforation	117	117
Thrombosis	84	84
Pseudoaneurysm	81	81
Fistula	77	77
Cardiac Arrest	68	68
Stroke/CVA	65	65
Hypoxia	57	57
Unspecified Tissue Injury	53	53
Arrhythmia	42	42
Insufficient Information	37	37
Perforation of Vessels	37	37
Tachycardia	36	36
Death	34	34
Cardiovascular Insufficiency	33	33
ST Segment Elevation	28	28
Embolism/Embolus	27	27
Chest Pain	26	26
Vascular System (Circulation), Impaired	26	26
Embolism	26	26
Bradycardia	25	25
Pain	23	23
Dyspnea	22	22
Tissue Damage	22	22
Heart Failure/Congestive Heart Failure	20	20
High Blood Pressure/ Hypertension	18	18
Transient Ischemic Attack	18	18
Inflammation	18	18
No Code Available	17	17
Vascular Dissection	17	17
Atrial Flutter	17	17
Myocardial Infarction	17	17
Heart Failure	17	17
Ventricular Fibrillation	15	15
Heart Block	15	15
Respiratory Distress	14	14
Atrial Fibrillation	13	13

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