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
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
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	551	551
Fracture	531	531
Detachment of Device or Device Component	305	305
Difficult to Remove	208	208
Degraded	166	166
Break	158	160
Adverse Event Without Identified Device or Use Problem	133	139
Crack	119	119
Material Split, Cut or Torn	81	81
Difficult to Advance	72	72
Fluid/Blood Leak	67	67
Device Contamination with Chemical or Other Material	50	50
Material Puncture/Hole	49	49
Physical Resistance/Sticking	42	42
Leak/Splash	38	38
Deformation Due to Compressive Stress	38	38
Material Deformation	37	37
Failure to Advance	35	35
Entrapment of Device	35	35
Device Contaminated During Manufacture or Shipping	32	32
Communication or Transmission Problem	30	30
Stretched	30	30
Material Protrusion/Extrusion	29	29
Material Integrity Problem	28	28
Material Fragmentation	27	27
Peeled/Delaminated	26	26
No Display/Image	26	26
Poor Quality Image	22	22
Material Twisted/Bent	21	21
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Improper or Incorrect Procedure or Method	19	19
Difficult or Delayed Positioning	18	18
Tear, Rip or Hole in Device Packaging	17	17
Device-Device Incompatibility	17	17
Material Frayed	17	17
Difficult to Insert	17	17
Defective Component	15	15
Unable to Obtain Readings	15	15
Obstruction of Flow	14	14
Material Rupture	13	13
Gas/Air Leak	13	13
Disconnection	13	13
Contamination	12	12
Air/Gas in Device	12	12
Use of Device Problem	10	10
Difficult to Open or Remove Packaging Material	9	9
Device Damaged by Another Device	9	9
Unraveled Material	9	9
Burst Container or Vessel	8	8
Delivered as Unsterile Product	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1811	1812
Foreign Body In Patient	277	277
Insufficient Information	97	98
Vascular Dissection	70	70
Thrombosis/Thrombus	30	30
Obstruction/Occlusion	27	30
Stroke/CVA	22	24
Vasoconstriction	16	16
Device Embedded In Tissue or Plaque	14	14
Cardiac Arrest	14	14
Hemorrhage/Bleeding	14	14
Non specific EKG/ECG Changes	13	13
Perforation of Vessels	13	13
Chest Pain	12	12
Low Blood Pressure/ Hypotension	12	12
Air Embolism	10	10
Ischemia	10	10
Pericardial Effusion	10	10
Ischemia Stroke	10	10
Ventricular Fibrillation	9	9
Intracranial Hemorrhage	9	9
Pain	8	8
Speech Disorder	8	8
Muscle Weakness	6	6
Angina	6	6
Dyspnea	6	6
Hematoma	6	6
Bradycardia	5	5
Cardiac Tamponade	5	5
Cardiogenic Shock	5	5
Rupture	5	5
Embolism/Embolus	5	5
Thromboembolism	4	5
Cardiac Perforation	4	4
Myocardial Infarction	4	4
Paralysis	4	4
Paresis	4	5
Hypersensitivity/Allergic reaction	4	4
Failure of Implant	4	4
Infiltration into Tissue	4	4
Inflammation	3	4
Encephalopathy	3	3
Pseudoaneurysm	3	3
Brain Injury	3	3
No Consequences Or Impact To Patient	3	3
Tachycardia	3	3
Laceration(s)	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	2	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2

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