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
1. K230411 Dragonfly OpStar™ Imaging Catheter
ACCURATE MEDICAL THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
ACCURATE MEDICAL THERAPEUTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
ACCURATE MEDICAL THERAPEUTICS 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
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
TERUMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	587	587
Fracture	567	567
Detachment of Device or Device Component	302	302
Difficult to Remove	199	199
Adverse Event Without Identified Device or Use Problem	178	178
Break	159	161
Crack	112	112
Degraded	110	110
Difficult to Advance	74	74
Material Split, Cut or Torn	73	73
Fluid/Blood Leak	65	65
Material Puncture/Hole	53	53
Device Contamination with Chemical or Other Material	49	49
Physical Resistance/Sticking	42	42
Material Deformation	41	41
Leak/Splash	37	37
Failure to Advance	36	36
Entrapment of Device	35	35
Deformation Due to Compressive Stress	33	33
Device Contaminated During Manufacture or Shipping	33	33
Communication or Transmission Problem	28	28
Material Integrity Problem	27	27
Material Twisted/Bent	26	26
Tear, Rip or Hole in Device Packaging	25	25
Peeled/Delaminated	24	24
Material Protrusion/Extrusion	24	24
Stretched	24	24
No Display/Image	22	22
Material Fragmentation	22	22
Material Rupture	20	20
Difficult to Insert	20	20
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Poor Quality Image	19	19
Material Frayed	18	18
Difficult or Delayed Positioning	17	17
Gas/Air Leak	16	16
Device-Device Incompatibility	16	16
Improper or Incorrect Procedure or Method	16	16
Unable to Obtain Readings	15	15
Defective Component	15	15
Separation Problem	13	13
Obstruction of Flow	13	13
Use of Device Problem	12	12
Disconnection	12	12
Contamination	11	11
Defective Device	10	10
Burst Container or Vessel	10	10
Difficult to Open or Remove Packaging Material	10	10
Contamination /Decontamination Problem	9	9
Unraveled Material	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1624	1625
Foreign Body In Patient	271	271
No Consequences Or Impact To Patient	115	115
Insufficient Information	82	83
Vascular Dissection	82	82
No Known Impact Or Consequence To Patient	39	39
No Patient Involvement	38	38
Thrombosis/Thrombus	33	33
Device Embedded In Tissue or Plaque	29	29
Obstruction/Occlusion	26	26
Stroke/CVA	23	23
No Code Available	20	20
Perforation of Vessels	18	18
Cardiac Arrest	16	16
Vasoconstriction	15	15
Hemorrhage/Bleeding	14	14
Chest Pain	14	14
Non specific EKG/ECG Changes	13	13
Air Embolism	11	11
Intracranial Hemorrhage	11	11
Low Blood Pressure/ Hypotension	10	10
Ischemia	10	10
Pericardial Effusion	10	10
Ventricular Fibrillation	9	9
Speech Disorder	8	8
Pain	8	8
Rupture	8	8
Cardiac Perforation	7	7
Hematoma	7	7
Ischemia Stroke	6	6
Myocardial Infarction	6	6
Death	6	6
Dyspnea	6	6
Muscle Weakness	6	6
Bradycardia	5	5
Cardiogenic Shock	5	5
Paralysis	5	5
Angina	5	5
Cardiac Tamponade	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	4
Paresis	4	4
Encephalopathy	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	Cook Incorporated	I	Jun-16-2025
6	Cordis Corporation	I	Sep-15-2021
7	Cordis US Corp	I	Nov-09-2023
8	Cordis US Corp	II	Dec-16-2022
9	Stryker Neurovascular	II	May-28-2024
10	Stryker Neurovascular	II	Jul-15-2022
11	Stryker, Inc.	II	Feb-14-2024
12	Vascular Solutions, Inc.	I	Oct-20-2020
13	Vascular Solutions, Inc.	I	Apr-27-2020