TPLC - Total Product Life Cycle

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Device	catheter, ultrasound, intravascular
Regulation Description	Diagnostic intravascular catheter.
Definition	For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product Code	OBJ
Regulation Number	870.1200
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACIST MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOSENSE WEBSTER, INC.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
LUMA VISION LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NORTHEAST SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS IMAGE GUIDED THERAPY CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PROVISIO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS MEDICAL SOLUTIONS USA, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	866	1232
Poor Quality Image	598	598
Entrapment of Device	525	891
Detachment of Device or Device Component	505	505
Material Twisted/Bent	289	289
Material Integrity Problem	250	250
Fracture	247	247
Material Deformation	226	348
Failure to Advance	155	155
Patient Device Interaction Problem	98	98
Physical Resistance/Sticking	97	97
Material Separation	95	827
Contamination /Decontamination Problem	76	76
No Display/Image	53	175
Unable to Obtain Readings	50	50
Connection Problem	28	28
Break	27	27
Device Displays Incorrect Message	26	26
Material Perforation	25	25
Difficult to Flush	25	25
Leak/Splash	24	24
Display or Visual Feedback Problem	24	24
Incorrect, Inadequate or Imprecise Result or Readings	23	23
Retraction Problem	22	22
Difficult to Advance	22	22
Difficult to Remove	19	263
Contamination	16	16
Communication or Transmission Problem	16	16
Defective Device	14	14
Device-Device Incompatibility	13	13
Mechanical Jam	12	12
Output Problem	12	12
Device Contamination with Chemical or Other Material	12	12
Activation, Positioning or Separation Problem	11	11
Material Puncture/Hole	10	10
Positioning Problem	10	10
Tear, Rip or Hole in Device Packaging	10	10
Insufficient Information	9	9
Therapeutic or Diagnostic Output Failure	9	9
Mechanical Problem	9	9
Difficult to Insert	9	9
Noise, Audible	8	8
Packaging Problem	8	8
Device Sensing Problem	8	8
Component Missing	8	8
Delivered as Unsterile Product	7	7
Unsealed Device Packaging	6	6
Incorrect Measurement	5	5
Sharp Edges	5	5
Failure to Power Up	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2494	3226
No Consequences Or Impact To Patient	172	172
Cardiac Tamponade	77	77
Insufficient Information	73	73
Foreign Body In Patient	65	309
No Known Impact Or Consequence To Patient	46	534
Cardiac Perforation	36	158
Air Embolism	34	34
Non specific EKG/ECG Changes	33	33
Cardiac Arrest	24	24
Vascular Dissection	23	145
Obstruction/Occlusion	16	16
Thrombosis/Thrombus	16	16
Chest Pain	15	15
No Patient Involvement	15	15
Pericardial Effusion	14	14
Perforation of Vessels	13	257
No Code Available	10	10
Myocardial Infarction	10	10
Ventricular Fibrillation	10	10
Arrhythmia	9	9
Perforation	8	8
Bradycardia	8	8
Low Blood Pressure/ Hypotension	7	7
Tachycardia	7	7
Complaint, Ill-Defined	6	6
Death	5	5
Heart Block	5	5
Embolism/Embolus	5	5
Hemorrhage/Bleeding	4	4
Ischemia	4	4
Unspecified Tissue Injury	4	4
Device Embedded In Tissue or Plaque	3	3
Pseudoaneurysm	3	3
Great Vessel Perforation	3	3
Hematoma	3	3
Ischemic Heart Disease	3	3
Pulmonary Edema	3	3
Restenosis	2	2
Stenosis	2	2
Cardiogenic Shock	2	2
Pericarditis	2	2
Rupture	2	2
Diminished Pulse Pressure	2	2
Failure of Implant	2	2
Stroke/CVA	2	2
Needle Stick/Puncture	1	1
Pleural Effusion	1	1
Thrombosis	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Acist Medical Systems	I	Mar-04-2021
2	Boston Scientific Corporation	II	Mar-28-2024
3	Boston Scientific Corporation	II	Oct-22-2020
4	Siemens Medical Solutions USA, Inc.	II	Oct-08-2020
5	Volcano Corp	III	Jun-29-2022