TPLC - Total Product Life Cycle

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Device	catheters, transluminal coronary angioplasty, percutaneous
Regulation Description	Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
Definition	A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.
Product Code	LOX
Regulation Number	870.5100
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
BIOTRONIK, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BROSMED MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
DONGGUAN TT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDCAPTAIN LIFE SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, IRELAND
	SUBSTANTIALLY EQUIVALENT	1
NATEC MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ORBUSNEICH MEDICAL TRADING, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
SINO MEDICAL SCIENCES TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
SIS MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
VERGE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	6402	6403
Difficult to Remove	1248	1248
Difficult to Advance	1159	1159
Break	982	983
Adverse Event Without Identified Device or Use Problem	909	909
Material Separation	658	658
Failure to Advance	641	641
Deflation Problem	612	612
Improper or Incorrect Procedure or Method	529	529
Burst Container or Vessel	374	374
Inflation Problem	373	374
Material Deformation	356	356
Detachment of Device or Device Component	354	356
Leak/Splash	299	299
Entrapment of Device	265	265
Failure to Deflate	184	184
Deformation Due to Compressive Stress	140	140
Nonstandard Device	127	127
Material Split, Cut or Torn	125	125
Material Integrity Problem	121	121
Fracture	98	98
Off-Label Use	78	78
Failure to Fold	69	69
Device Markings/Labelling Problem	67	67
Defective Device	38	38
Physical Resistance/Sticking	35	35
Material Puncture/Hole	35	35
Stretched	31	31
Use of Device Problem	30	30
Device-Device Incompatibility	28	28
Difficult to Open or Remove Packaging Material	25	25
Contamination	25	25
Device Dislodged or Dislocated	23	23
Device Damaged by Another Device	21	21
Device Contamination with Chemical or Other Material	20	20
Difficult to Insert	19	19
Positioning Problem	17	17
Packaging Problem	15	15
Product Quality Problem	14	14
Component Missing	14	14
Unintended System Motion	12	12
Illegible Information	12	12
Obstruction of Flow	12	12
Tear, Rip or Hole in Device Packaging	11	11
Unsealed Device Packaging	11	11
Insufficient Information	11	11
Material Fragmentation	8	8
Material Twisted/Bent	8	8
Fluid/Blood Leak	8	8
Difficult or Delayed Positioning	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8245	8246
No Consequences Or Impact To Patient	1720	1720
Insufficient Information	326	327
Vascular Dissection	260	260
Myocardial Infarction	196	196
Foreign Body In Patient	170	171
Cardiac Arrest	145	145
Obstruction/Occlusion	137	137
Device Embedded In Tissue or Plaque	126	126
Perforation of Vessels	124	124
Cardiogenic Shock	115	115
Hemorrhage/Bleeding	94	94
No Patient Involvement	91	91
Low Blood Pressure/ Hypotension	90	90
Heart Failure/Congestive Heart Failure	90	90
No Known Impact Or Consequence To Patient	74	74
Arrhythmia	67	67
Perforation	66	67
Chest Pain	61	61
Hematoma	59	60
Embolism/Embolus	54	54
Ischemia	48	48
Angina	45	45
Unspecified Kidney or Urinary Problem	45	45
Non specific EKG/ECG Changes	44	44
Thrombosis/Thrombus	39	39
Air Embolism	38	38
Unspecified Heart Problem	29	29
Bradycardia	29	29
Death	23	23
Pericardial Effusion	21	21
Unspecified Tissue Injury	20	20
Injury	20	20
Cardiac Tamponade	19	19
Pain	19	19
Ventricular Fibrillation	17	17
Tachycardia	16	16
No Code Available	15	15
High Blood Pressure/ Hypertension	15	15
Stenosis	13	13
Vasoconstriction	11	11
Restenosis	10	10
Atrial Fibrillation	9	9
Pulmonary Edema	7	7
Occlusion	7	7
Dyspnea	7	7
Unspecified Infection	7	7
Hypoxia	6	6
Shock	6	6
Extravasation	6	7