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
ASAHI INTECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	10
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	6
FLAT MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FMD CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
LAKE REGION MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL IRELAND , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL IRELAND, LTD.
	SUBSTANTIALLY EQUIVALENT	4
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NANO4IMAGING GMBH
	SUBSTANTIALLY EQUIVALENT	1
OPSENS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SEVEN SONS , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOLO PACE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SP MEDICAL A/S
	SUBSTANTIALLY EQUIVALENT	1
SPARTAN MICRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUREAX MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
VASCULAR SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	2
VOLCANO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM COOK EUROPE APS
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	1713	3066
2022	1647	1649
2023	2068	2073
2024	2210	2215
2025	2201	2201
2026	1344	1344

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	1567	2303
Difficult to Remove	1336	1336
Difficult to Advance	1124	1125
Fracture	1021	1022
Adverse Event Without Identified Device or Use Problem	1007	1009
Detachment of Device or Device Component	912	912
Break	886	888
Peeled/Delaminated	809	810
Entrapment of Device	533	1143
Failure to Advance	430	431
Deformation Due to Compressive Stress	387	387
Unraveled Material	371	373
Insufficient Device Problem Information	326	326
Material Split, Cut or Torn	319	319
Stretched	304	305
Material Deformation	300	300
Physical Resistance/Sticking	299	299
Material Twisted/Bent	297	297
Material Integrity Problem	278	279
Improper or Incorrect Procedure or Method	204	204
Patient Device Interaction Problem	117	119
Product Quality Problem	96	96
Device Contaminated During Manufacture or Shipping	88	88
Incorrect Measurement	87	87
Positioning Problem	85	85
Material Fragmentation	73	73
Leak/Splash	72	73
Material Too Soft/Flexible	63	63
Mechanical Jam	62	62
Flaked	60	60
Device Damaged by Another Device	60	60
Material Frayed	58	58
Material Protrusion/Extrusion	55	55
Fluid/Blood Leak	49	49
Off-Label Use	47	47
Difficult to Insert	46	46
Use of Device Problem	45	45
Component Misassembled	42	42
Contamination /Decontamination Problem	37	37
Loose or Intermittent Connection	36	36
Activation, Positioning or Separation Problem	36	36
Device-Device Incompatibility	33	33
Device Contamination with Chemical or Other Material	31	31
Tear, Rip or Hole in Device Packaging	29	29
Malposition of Device	28	28
Appropriate Device Problem Term/Code Not Available	26	26
No Apparent Adverse Event	24	24
Material Too Rigid or Stiff	23	23
Sharp Edges	22	144
Unsealed Device Packaging	21	21

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6776	7885
Foreign Body In Patient	1637	1641
Vascular Dissection	618	742
Insufficient Information	528	533
Perforation of Vessels	389	511
Device Embedded In Tissue or Plaque	338	338
Pericardial Effusion	241	243
Cardiac Tamponade	238	238
Low Blood Pressure/ Hypotension	190	191
Perforation	184	186
Cardiac Perforation	179	179
Hemorrhage/Blood Loss/Bleeding	154	155
Myocardial Infarction	128	128
Hemoptysis	92	92
Obstruction/Occlusion	89	89
Hematoma	67	67
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	65	65
Stroke/CVA	62	62
Embolism/Embolus	56	57
Cardiac Arrest	56	56
Pain	54	54
Thrombosis/Thrombus	43	43
Unspecified Tissue Injury	40	40
No Consequences Or Impact To Patient	36	36
Intracranial Hemorrhage	30	30
Heart Block	25	25
Bradycardia	24	24
Vasoconstriction	24	24
Rupture	23	23
Tachycardia	22	22
Chest Pain	20	20
Laceration(s)	17	17
Cardiomyopathy	15	15
Needle Stick/Puncture	15	15
Aortic dissection	14	14
Extravasation	13	13
Thromboembolism	13	13
Ventricular Fibrillation	13	13
Foreign Body Embolism	13	13
Pulmonary Edema	12	12
Ischemia	12	12
Great Vessel Perforation	12	13
Non specific EKG/ECG Changes	11	11
Failure of Implant	11	11
Ischemia Stroke	11	11
Discomfort	10	10
Hemodynamic instability	10	10
Valvular Insufficiency/ Regurgitation	10	10
Aortic Valve Insufficiency/ Regurgitation	10	10
Renal Impairment	10	10

Recalls
Manufacturer		Recall Class	Date Posted
1	ARROW INTERNATIONAL Inc.	II	Sep-26-2024
2	ARROW INTERNATIONAL Inc.	I	Mar-21-2024
3	ARROW INTERNATIONAL, LLC	I	Jun-13-2026
4	Bard Peripheral Vascular Inc	II	Sep-06-2024
5	Cook Incorporated	II	Apr-06-2026
6	Cook Incorporated	II	Nov-21-2024
7	Cook Incorporated	II	Nov-08-2024
8	Cook Incorporated	II	Sep-28-2022
9	Cook Incorporated	II	Sep-09-2022
10	Galt Medical Corporation	II	Aug-07-2026
11	Galt Medical Corporation	II	May-07-2025
12	Medline Industries, LP	II	Apr-17-2026
13	Merit Medical Systems, Inc.	II	Jun-18-2026
14	Stryker Neurovascular	II	May-31-2024
15	Stryker Neurovascular	II	May-28-2024