TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
ACCURATE MEDICAL THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
ACCURATE MEDICAL THERAPEUTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
ACCURATE MEDICAL THERAPEUTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEND IT TECHNOLOGIES LTD
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CORDIS US CORP.
	SUBSTANTIALLY EQUIVALENT	1
EMBOLX, INC.
	SUBSTANTIALLY EQUIVALENT	1
GENTUITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PFM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PHENOX LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	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	558	558
Fracture	553	553
Detachment of Device or Device Component	296	296
Adverse Event Without Identified Device or Use Problem	198	198
Difficult to Remove	158	158
Break	141	141
Crack	89	89
Difficult to Advance	60	60
Material Puncture/Hole	58	58
Fluid/Blood Leak	50	50
Material Split, Cut or Torn	41	41
Device Contamination with Chemical or Other Material	39	39
Material Deformation	34	34
Device-Device Incompatibility	28	28
Device Contaminated During Manufacture or Shipping	28	28
Entrapment of Device	28	28
Failure to Advance	28	28
Material Twisted/Bent	27	27
Material Integrity Problem	27	27
Physical Resistance/Sticking	26	26
Leak/Splash	22	22
Failure to Align	22	22
Tear, Rip or Hole in Device Packaging	22	22
Difficult to Insert	22	22
Deformation Due to Compressive Stress	21	21
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Gas/Air Leak	18	18
Material Rupture	17	17
Communication or Transmission Problem	17	17
Unable to Obtain Readings	16	16
Material Fragmentation	16	16
Separation Problem	15	15
Peeled/Delaminated	15	15
No Display/Image	15	15
Material Frayed	13	13
Degraded	13	13
Delivered as Unsterile Product	12	12
Improper or Incorrect Procedure or Method	12	12
Stretched	11	11
Poor Quality Image	11	11
Defective Device	10	10
Disconnection	9	9
Structural Problem	9	9
Obstruction of Flow	9	9
Use of Device Problem	9	9
Contamination	8	8
Contamination /Decontamination Problem	8	8
Positioning Problem	8	8
Device Damaged by Another Device	8	8
Unraveled Material	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1057	1057
Foreign Body In Patient	255	255
No Consequences Or Impact To Patient	230	230
No Known Impact Or Consequence To Patient	96	96
Vascular Dissection	91	91
No Patient Involvement	68	68
Insufficient Information	55	55
Device Embedded In Tissue or Plaque	48	48
Perforation of Vessels	44	44
No Code Available	35	35
Thrombosis/Thrombus	20	20
Cardiac Arrest	18	18
Stroke/CVA	18	18
Occlusion	18	18
Obstruction/Occlusion	16	16
Death	16	16
Vasoconstriction	14	14
Perforation	14	14
Thrombosis	13	13
Hemorrhage/Bleeding	12	12
Low Blood Pressure/ Hypotension	12	12
No Information	11	11
Coagulation Disorder	8	8
Chest Pain	8	8
Cardiac Perforation	8	8
Rupture	8	8
Ventricular Fibrillation	7	7
Pericardial Effusion	7	7
Air Embolism	7	7
Pain	6	6
Hematoma	6	6
Pulmonary Embolism	6	6
Blood Loss	6	6
Paresis	5	5
Dyspnea	5	5
Cardiogenic Shock	5	5
Intracranial Hemorrhage	5	5
Coma	4	4
Bradycardia	4	4
Renal Failure	4	4
Vascular System (Circulation), Impaired	4	4
Embolism	4	4
Myocardial Infarction	4	4
Muscle Spasm(s)	4	4
Thromboembolism	4	4
Internal Organ Perforation	4	4
Ischemia Stroke	4	4
Injury	4	4
Angina	4	4
Embolus	4	4

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 Inc.	II	Nov-18-2019
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