TPLC - Total Product Life Cycle

• Device: wire, guide, catheter
• Regulation Description: Catheter guide wire.
• Product Code: DQX
• Regulation Number: 870.1330
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
ABBOTT VASCULAR
	SUBSTANTIALLY EQUIVALENT	2
ASAHI INTECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	11
BAYLIS MEDICAL COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOMERICS NLE
	SUBSTANTIALLY EQUIVALENT	2
CARDIO FLOW INC.,
	SUBSTANTIALLY EQUIVALENT	1
CENTURION MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
EMBRACE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
FILMEC CO. , LTD.
	SUBSTANTIALLY EQUIVALENT	2
FILMECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	5
FLAT MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FMD CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
LAKE REGION MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
1.  K232570  Steerant™ Super Stiff Guidewire
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL IRELAND, LTD.
	SUBSTANTIALLY EQUIVALENT	3
MERIT MEDICAL SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	3
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	2
NANO4IMAGING GMBH
	SUBSTANTIALLY EQUIVALENT	1
OPSENS, INC.
	SUBSTANTIALLY EQUIVALENT	3
SCIENTIA VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEVEN SONS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLO PACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPARTAN MICRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUREAX MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HENGRUI DISHENG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
VASCULAR SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	2
VESATEK, LLC
	SUBSTANTIALLY EQUIVALENT	1
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
WILLIAM COOK EUROPE APS
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2020	1536	2028
2021	1713	3066
2022	1647	1649
2023	2068	2073
2024	2210	2215
2025	2201	2201
2026	525	525

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	1805	2788
Difficult to Remove	1489	1489
Difficult to Advance	1182	1183
Fracture	1159	1160
Break	1100	1103
Detachment of Device or Device Component	1064	1065
Adverse Event Without Identified Device or Use Problem	1032	1156
Peeled/Delaminated	857	858
Entrapment of Device	652	1629
Failure to Advance	491	492
Unraveled Material	431	434
Deformation Due to Compressive Stress	420	420
Material Deformation	385	385
Physical Resistance/Sticking	371	371
Material Split, Cut or Torn	355	355
Stretched	349	350
Insufficient Information	335	335
Material Integrity Problem	334	335
Material Twisted/Bent	328	328
Improper or Incorrect Procedure or Method	239	239
Product Quality Problem	108	108
Positioning Problem	107	107
Material Fragmentation	93	93
Patient Device Interaction Problem	93	95
Material Frayed	91	91
Device Contaminated During Manufacture or Shipping	89	89
Incorrect Measurement	89	89
Device Damaged by Another Device	75	75
Leak/Splash	71	72
Material Too Soft/Flexible	70	70
Flaked	67	67
Off-Label Use	66	66
Material Protrusion/Extrusion	65	65
Difficult to Insert	57	57
Use of Device Problem	55	55
Fluid/Blood Leak	53	53
Contamination /Decontamination Problem	48	48
Component Misassembled	47	47
Activation, Positioning or Separation Problem	46	46
Mechanical Jam	43	43
Defective Device	41	41
Device-Device Incompatibility	34	34
Device Contamination with Chemical or Other Material	32	32
Device Dislodged or Dislocated	31	31
Loose or Intermittent Connection	31	31
Material Too Rigid or Stiff	27	27
Obstruction of Flow	26	26
Malposition of Device	26	26
Difficult or Delayed Positioning	24	25
Appropriate Term/Code Not Available	24	24

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6472	7583
Foreign Body In Patient	1630	1634
No Consequences Or Impact To Patient	662	662
Vascular Dissection	618	742
Insufficient Information	530	536
Device Embedded In Tissue or Plaque	481	483
Perforation of Vessels	413	535
Cardiac Tamponade	231	231
Pericardial Effusion	212	214
Perforation	207	209
Low Blood Pressure/ Hypotension	187	188
Cardiac Perforation	182	182
Hemorrhage/Bleeding	148	149
Myocardial Infarction	146	146
No Known Impact Or Consequence To Patient	142	632
Obstruction/Occlusion	84	84
Hemoptysis	82	82
Stroke/CVA	77	77
Cardiac Arrest	62	62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	62	62
No Patient Involvement	61	61
Hematoma	60	60
Vessel Or Plaque, Device Embedded In	59	59
Embolism/Embolus	54	55
Pain	52	52
Death	45	45
No Code Available	44	44
Thrombosis/Thrombus	43	43
Unspecified Tissue Injury	34	34
Intimal Dissection	32	32
Intracranial Hemorrhage	31	31
Vasoconstriction	30	30
Embolism	26	26
Bradycardia	24	24
Laceration(s)	23	23
Chest Pain	22	22
Rupture	22	22
Occlusion	19	19
Tachycardia	18	18
Unspecified Infection	18	18
Arrhythmia	16	16
Heart Block	16	16
Cardiomyopathy	15	15
Extravasation	15	15
Needle Stick/Puncture	15	15
Blood Loss	15	15
High Blood Pressure/ Hypertension	15	15
No Information	14	14
Ventricular Fibrillation	14	14
Calcium Deposits/Calcification	13	13

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL Inc.	II	Sep-26-2024
2	ARROW INTERNATIONAL Inc.	I	Mar-21-2024
3	Argon Medical Devices, Inc	I	May-07-2020
4	Arrow International Inc	II	Jan-23-2020
5	Bard Peripheral Vascular Inc	II	Sep-06-2024
6	Cook Inc.	I	Nov-03-2020
7	Cook Incorporated	II	Apr-06-2026
8	Cook Incorporated	II	Nov-21-2024
9	Cook Incorporated	II	Nov-08-2024
10	Cook Incorporated	II	Sep-28-2022
11	Cook Incorporated	II	Sep-09-2022
12	Galt Medical Corporation	II	May-07-2025
13	Medline Industries, LP	II	Apr-17-2026
14	Stryker Neurovascular	II	May-31-2024
15	Stryker Neurovascular	II	May-28-2024