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
JIANGSU TINGSN TECHNOLOGY CO., LTD.
	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
VOLCANO CORPORATION (DBA PHILIPS IMAGE GUIDED THERAPY DEVICE
	SUBSTANTIALLY EQUIVALENT	1
YORLABS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1003	1383
Poor Quality Image	679	685
Entrapment of Device	614	987
Detachment of Device or Device Component	536	537
Material Twisted/Bent	316	322
Fracture	291	291
Material Integrity Problem	289	290
Material Deformation	273	396
Failure to Advance	173	174
Physical Resistance/Sticking	126	127
Patient Device Interaction Problem	112	112
Material Separation	108	840
No Display/Image	89	211
Contamination /Decontamination Problem	80	80
Unable to Obtain Readings	67	67
Connection Problem	52	52
Difficult to Flush	43	43
Break	34	34
Device Displays Incorrect Message	34	34
Leak/Splash	29	29
Difficult to Advance	28	28
Contamination	28	28
Material Perforation	27	27
Display or Visual Feedback Problem	27	27
Retraction Problem	24	24
Incorrect, Inadequate or Imprecise Result or Readings	24	24
Difficult to Remove	20	264
Device-Device Incompatibility	19	19
Communication or Transmission Problem	17	17
Nonstandard Device	17	17
Mechanical Jam	17	17
Defective Device	17	17
Output Problem	16	16
Device Contamination with Chemical or Other Material	16	16
Device Sensing Problem	14	14
Activation, Positioning or Separation Problem	14	14
Air/Gas in Device	14	14
Material Puncture/Hole	13	13
Mechanical Problem	12	12
Positioning Problem	12	12
Tear, Rip or Hole in Device Packaging	11	11
Therapeutic or Diagnostic Output Failure	11	11
Image Display Error/Artifact	9	9
Insufficient Information	9	9
Difficult to Insert	9	9
Packaging Problem	9	9
Component Missing	8	8
Use of Device Problem	8	8
Sharp Edges	8	8
Noise, Audible	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2895	3643
No Consequences Or Impact To Patient	172	172
Cardiac Tamponade	86	86
Insufficient Information	77	77
Foreign Body In Patient	74	319
Cardiac Perforation	48	170
No Known Impact Or Consequence To Patient	46	534
Air Embolism	44	45
Non specific EKG/ECG Changes	40	40
Cardiac Arrest	31	31
Vascular Dissection	24	146
Thrombosis/Thrombus	19	19
Chest Pain	18	18
Obstruction/Occlusion	18	18
Pericardial Effusion	17	17
Perforation of Vessels	15	259
No Patient Involvement	15	15
Arrhythmia	13	13
Myocardial Infarction	12	12
No Code Available	10	10
Bradycardia	10	10
Perforation	10	10
Ventricular Fibrillation	10	10
Low Blood Pressure/ Hypotension	9	9
Tachycardia	7	7
Complaint, Ill-Defined	6	6
Embolism/Embolus	6	6
Death	5	5
Unspecified Tissue Injury	5	5
Ischemia	5	5
Heart Block	5	5
Hemorrhage/Bleeding	5	5
Great Vessel Perforation	4	4
Pulmonary Edema	4	4
Device Embedded In Tissue or Plaque	4	4
Hematoma	4	4
Pseudoaneurysm	3	3
Ischemic Heart Disease	3	3
Pericarditis	2	2
Cardiac Enzyme Elevation	2	2
Rupture	2	2
Diminished Pulse Pressure	2	2
Cardiogenic Shock	2	2
Discomfort	2	2
Pain	2	2
Stenosis	2	2
Restenosis	2	2
Failure of Implant	2	2
Stroke/CVA	2	2
Unspecified Vascular Problem	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	II	Jul-30-2025
7	Volcano Corp	III	Jun-29-2022