TPLC - Total Product Life Cycle

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Device	catheter, intravascular, diagnostic
Regulation Description	Diagnostic intravascular catheter.
Product Code	DQO
Regulation Number	870.1200
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ACCURATE MEDICAL THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
BIOPTIMAL INTERNATIONAL PTE. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CORDIS US CORP
	SUBSTANTIALLY EQUIVALENT	1
EMBOLX, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENTUITY, LLC
	SUBSTANTIALLY EQUIVALENT	2
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PFM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHENOX, LTD.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRUM VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CLINICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	565	565
Fracture	550	550
Detachment of Device or Device Component	349	349
Difficult to Remove	219	219
Degraded	200	200
Break	175	177
Crack	141	141
Adverse Event Without Identified Device or Use Problem	141	147
Material Split, Cut or Torn	88	88
Difficult to Advance	75	75
Fluid/Blood Leak	72	72
Material Puncture/Hole	52	52
Device Contamination with Chemical or Other Material	52	52
Physical Resistance/Sticking	46	46
Leak/Splash	43	43
Material Deformation	38	38
Deformation Due to Compressive Stress	38	38
Failure to Advance	36	36
Entrapment of Device	36	36
Material Protrusion/Extrusion	32	32
No Display/Image	32	32
Device Contaminated During Manufacture or Shipping	32	32
Communication or Transmission Problem	31	31
Peeled/Delaminated	31	31
Stretched	31	31
Material Fragmentation	31	31
Material Integrity Problem	30	30
Mechanical Problem	28	28
Poor Quality Image	23	23
Material Twisted/Bent	21	21
Incorrect, Inadequate or Imprecise Result or Readings	21	21
Improper or Incorrect Procedure or Method	20	20
Difficult or Delayed Positioning	18	18
Material Frayed	18	18
Tear, Rip or Hole in Device Packaging	17	17
Difficult to Insert	17	17
Device-Device Incompatibility	17	17
Obstruction of Flow	15	15
Unable to Obtain Readings	15	15
Defective Component	15	15
Material Rupture	14	14
Gas/Air Leak	13	13
Contamination	13	13
Disconnection	13	13
Air/Gas in Device	12	12
Use of Device Problem	11	11
Defective Device	10	10
Unraveled Material	10	10
Device Damaged by Another Device	10	10
Difficult to Open or Remove Packaging Material	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1996	1997
Foreign Body In Patient	301	301
Insufficient Information	100	101
Vascular Dissection	75	75
Thrombosis/Thrombus	31	31
Obstruction/Occlusion	27	30
Stroke/CVA	22	24
Vasoconstriction	16	16
Device Embedded In Tissue or Plaque	15	15
Hemorrhage/Bleeding	15	15
Cardiac Arrest	14	14
Non specific EKG/ECG Changes	13	13
Low Blood Pressure/ Hypotension	13	13
Perforation of Vessels	13	13
Chest Pain	12	12
Pericardial Effusion	12	12
Air Embolism	11	11
Ischemia Stroke	10	10
Ischemia	10	10
Intracranial Hemorrhage	9	9
Ventricular Fibrillation	9	9
Pain	8	8
Speech Disorder	8	8
Cardiac Tamponade	8	8
Hematoma	6	6
Muscle Weakness	6	6
Dyspnea	6	6
Angina	6	6
Myocardial Infarction	5	5
Embolism/Embolus	5	5
Bradycardia	5	5
Rupture	5	5
Cardiogenic Shock	5	5
Cardiac Perforation	5	5
Thromboembolism	4	5
Infiltration into Tissue	4	4
Paresis	4	5
Failure of Implant	4	4
Hypersensitivity/Allergic reaction	4	4
Paralysis	4	4
Encephalopathy	3	3
No Consequences Or Impact To Patient	3	3
Pseudoaneurysm	3	3
Unspecified Tissue Injury	3	3
Tachycardia	3	3
Laceration(s)	3	3
Brain Injury	3	3
Inflammation	3	4
Arrhythmia	2	2
Foreign Body Embolism	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Vascular	I	May-19-2022
2	Angiodynamics, Inc.	II	Apr-17-2026
3	Angiodynamics, Inc.	II	Jul-31-2024
4	Boston Scientific Corporation	I	May-10-2024
5	Cook Incorporated	I	May-01-2026
6	Cook Incorporated	II	Apr-06-2026
7	Cook Incorporated	I	Jun-16-2025
8	Cordis Corporation	I	Sep-15-2021
9	Cordis US Corp	I	Nov-09-2023
10	Cordis US Corp	II	Dec-16-2022
11	Gentuity, LLC	II	Apr-16-2026
12	Stryker Neurovascular	II	May-28-2024
13	Stryker Neurovascular	II	Jul-15-2022
14	Stryker, Inc.	II	Feb-14-2024