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
1. K202797 Drakon and Sequre Microcatheters
ACCURATE MEDICAL THERAPEUTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
1. K202797 Drakon and Sequre Microcatheters
ACCURATE MEDICAL THERAPEUTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K202797 Drakon and Sequre Microcatheters
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
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CLINICAL SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	530	530
Fracture	504	504
Detachment of Device or Device Component	268	268
Difficult to Remove	162	162
Adverse Event Without Identified Device or Use Problem	157	157
Break	130	130
Crack	97	97
Difficult to Advance	63	63
Fluid/Blood Leak	52	52
Material Puncture/Hole	50	50
Material Split, Cut or Torn	50	50
Device Contamination with Chemical or Other Material	41	41
Material Deformation	37	37
Leak/Splash	31	31
Physical Resistance/Sticking	31	31
Failure to Advance	30	30
Entrapment of Device	28	28
Device Contaminated During Manufacture or Shipping	28	28
Degraded	27	27
Material Twisted/Bent	26	26
Deformation Due to Compressive Stress	26	26
Tear, Rip or Hole in Device Packaging	23	23
Communication or Transmission Problem	21	21
Difficult to Insert	19	19
Material Rupture	18	18
Material Fragmentation	18	18
Peeled/Delaminated	17	17
Incorrect, Inadequate or Imprecise Result or Readings	17	17
No Display/Image	16	16
Gas/Air Leak	16	16
Material Frayed	16	16
Stretched	15	15
Unable to Obtain Readings	15	15
Material Integrity Problem	15	15
Device-Device Incompatibility	14	14
Improper or Incorrect Procedure or Method	13	13
Separation Problem	12	12
Poor Quality Image	12	12
Use of Device Problem	11	11
Obstruction of Flow	10	10
Device Damaged by Another Device	9	9
Disconnection	9	9
Defective Device	8	8
Unraveled Material	8	8
Structural Problem	8	8
Burst Container or Vessel	8	8
Contamination	7	7
Contamination /Decontamination Problem	7	7
Difficult or Delayed Positioning	7	7
Material Protrusion/Extrusion	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1262	1262
Foreign Body In Patient	231	231
No Consequences Or Impact To Patient	115	115
Vascular Dissection	77	77
Insufficient Information	61	61
No Known Impact Or Consequence To Patient	39	39
No Patient Involvement	38	38
Thrombosis/Thrombus	30	30
Device Embedded In Tissue or Plaque	29	29
Stroke/CVA	23	23
No Code Available	20	20
Obstruction/Occlusion	20	20
Perforation of Vessels	17	17
Cardiac Arrest	15	15
Chest Pain	13	13
Hemorrhage/Bleeding	12	12
Vasoconstriction	12	12
Non specific EKG/ECG Changes	9	9
Low Blood Pressure/ Hypotension	9	9
Air Embolism	8	8
Speech Disorder	8	8
Rupture	8	8
Ventricular Fibrillation	7	7
Pericardial Effusion	7	7
Hematoma	7	7
Ischemia	7	7
Dyspnea	6	6
Cardiac Perforation	6	6
Death	6	6
Muscle Weakness	5	5
Ischemia Stroke	5	5
Occlusion	5	5
Cardiac Tamponade	5	5
Myocardial Infarction	5	5
Intracranial Hemorrhage	5	5
Paralysis	5	5
Failure of Implant	5	5
Cardiogenic Shock	5	5
Embolism/Embolus	4	4
Thromboembolism	4	4
Angina	4	4
Renal Failure	4	4
Hypersensitivity/Allergic reaction	4	4
Arrhythmia	4	4
Pain	4	4
Paresis	4	4
Encephalopathy	3	3
Inflammation	3	3
No Information	3	3
Infiltration into Tissue	3	3

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	Boston Scientific Corporation	I	Mar-25-2020
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
11	Vascular Solutions, Inc.	I	Oct-20-2020
12	Vascular Solutions, Inc.	I	Apr-27-2020