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
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
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	3
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	898	1264
Poor Quality Image	618	618
Entrapment of Device	546	912
Detachment of Device or Device Component	511	511
Material Twisted/Bent	296	296
Material Integrity Problem	263	263
Fracture	258	258
Material Deformation	239	361
Failure to Advance	159	159
Material Separation	102	834
Physical Resistance/Sticking	102	102
Patient Device Interaction Problem	100	100
Contamination /Decontamination Problem	76	76
No Display/Image	58	180
Unable to Obtain Readings	52	52
Connection Problem	36	36
Break	28	28
Display or Visual Feedback Problem	27	27
Difficult to Flush	27	27
Device Displays Incorrect Message	27	27
Leak/Splash	26	26
Material Perforation	25	25
Difficult to Advance	23	23
Incorrect, Inadequate or Imprecise Result or Readings	23	23
Retraction Problem	22	22
Difficult to Remove	20	264
Contamination	17	17
Communication or Transmission Problem	16	16
Defective Device	15	15
Device-Device Incompatibility	14	14
Mechanical Jam	14	14
Device Contamination with Chemical or Other Material	13	13
Output Problem	12	12
Activation, Positioning or Separation Problem	12	12
Material Puncture/Hole	12	12
Tear, Rip or Hole in Device Packaging	11	11
Device Sensing Problem	10	10
Therapeutic or Diagnostic Output Failure	10	10
Positioning Problem	10	10
Insufficient Information	9	9
Difficult to Insert	9	9
Mechanical Problem	9	9
Packaging Problem	9	9
Component Missing	8	8
Noise, Audible	8	8
Image Display Error/Artifact	7	7
Delivered as Unsterile Product	7	7
Unsealed Device Packaging	6	6
Failure to Power Up	6	6
Sharp Edges	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2594	3326
No Consequences Or Impact To Patient	172	172
Cardiac Tamponade	78	78
Insufficient Information	75	75
Foreign Body In Patient	67	311
No Known Impact Or Consequence To Patient	46	534
Cardiac Perforation	38	160
Air Embolism	35	35
Non specific EKG/ECG Changes	34	34
Cardiac Arrest	26	26
Vascular Dissection	23	145
Obstruction/Occlusion	17	17
Thrombosis/Thrombus	17	17
Chest Pain	15	15
No Patient Involvement	15	15
Pericardial Effusion	14	14
Perforation of Vessels	14	258
Arrhythmia	10	10
No Code Available	10	10
Myocardial Infarction	10	10
Ventricular Fibrillation	10	10
Perforation	8	8
Bradycardia	8	8
Low Blood Pressure/ Hypotension	7	7
Tachycardia	7	7
Complaint, Ill-Defined	6	6
Embolism/Embolus	6	6
Death	5	5
Heart Block	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	Conavi Medical Inc.	I	Apr-23-2025
5	Siemens Medical Solutions USA, Inc.	II	Oct-08-2020
6	Volcano Corp	III	Jun-29-2022