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
ACCURATE MEDICAL THERAPEUTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
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
SUZHOU HENGRUI DISHENG MEDICAL CO., LTD.
	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	622	622
Fracture	611	611
Detachment of Device or Device Component	420	420
Difficult to Remove	230	230
Degraded	200	200
Break	197	199
Adverse Event Without Identified Device or Use Problem	195	201
Crack	147	147
Material Split, Cut or Torn	92	92
Difficult to Advance	82	82
Fluid/Blood Leak	74	74
Material Puncture/Hole	58	58
Device Contamination with Chemical or Other Material	56	56
Physical Resistance/Sticking	47	47
Leak/Splash	46	46
Material Deformation	44	44
Deformation Due to Compressive Stress	40	40
Failure to Advance	40	40
Entrapment of Device	38	38
Communication or Transmission Problem	35	35
Material Fragmentation	33	33
Device Contaminated During Manufacture or Shipping	33	33
Material Protrusion/Extrusion	33	33
Material Integrity Problem	32	32
No Display/Image	32	32
Stretched	31	31
Peeled/Delaminated	31	31
Mechanical Problem	28	28
Material Twisted/Bent	27	27
Tear, Rip or Hole in Device Packaging	26	26
Poor Quality Image	23	23
Difficult to Insert	21	21
Incorrect, Inadequate or Imprecise Result or Readings	21	21
Material Rupture	21	21
Improper or Incorrect Procedure or Method	20	20
Material Frayed	19	19
Difficult or Delayed Positioning	18	18
Device-Device Incompatibility	17	17
Gas/Air Leak	16	16
Defective Component	15	15
Obstruction of Flow	15	15
Unable to Obtain Readings	15	15
Defective Device	13	13
Use of Device Problem	13	13
Contamination	13	13
Separation Problem	13	13
Disconnection	13	13
Air/Gas in Device	12	12
Unraveled Material	11	11
Device Damaged by Another Device	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2038	2039
Foreign Body In Patient	317	317
No Consequences Or Impact To Patient	115	115
Insufficient Information	102	103
Vascular Dissection	90	90
No Known Impact Or Consequence To Patient	39	39
No Patient Involvement	38	38
Thrombosis/Thrombus	34	34
Device Embedded In Tissue or Plaque	30	30
Obstruction/Occlusion	27	30
Stroke/CVA	24	26
No Code Available	20	20
Perforation of Vessels	18	18
Hemorrhage/Bleeding	16	16
Vasoconstriction	16	16
Cardiac Arrest	16	16
Non specific EKG/ECG Changes	14	14
Chest Pain	14	14
Air Embolism	13	13
Low Blood Pressure/ Hypotension	13	13
Pericardial Effusion	12	12
Intracranial Hemorrhage	11	11
Ischemia Stroke	10	10
Ischemia	10	10
Cardiac Tamponade	10	10
Ventricular Fibrillation	9	9
Speech Disorder	8	8
Pain	8	8
Cardiac Perforation	8	8
Rupture	8	8
Myocardial Infarction	7	7
Hematoma	7	7
Death	6	6
Dyspnea	6	6
Muscle Weakness	6	6
Angina	6	6
Bradycardia	5	5
Cardiogenic Shock	5	5
Paralysis	5	5
Arrhythmia	5	5
Embolism/Embolus	5	5
Occlusion	5	5
Failure of Implant	5	5
Infiltration into Tissue	4	4
Pseudoaneurysm	4	4
Hypersensitivity/Allergic reaction	4	4
Renal Failure	4	4
Thromboembolism	4	5
Paresis	4	5
Encephalopathy	3	3

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	Boston Scientific Corporation	I	Mar-25-2020
6	Cook Incorporated	I	May-01-2026
7	Cook Incorporated	II	Apr-06-2026
8	Cook Incorporated	I	Jun-16-2025
9	Cordis Corporation	I	Sep-15-2021
10	Cordis US Corp	I	Nov-09-2023
11	Cordis US Corp	II	Dec-16-2022
12	Gentuity, LLC	II	Apr-16-2026
13	Stryker Neurovascular	II	May-28-2024
14	Stryker Neurovascular	II	Jul-15-2022
15	Stryker, Inc.	II	Feb-14-2024
16	Vascular Solutions, Inc.	I	Oct-20-2020
17	Vascular Solutions, Inc.	I	Apr-27-2020