TPLC - Total Product Life Cycle

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Device	catheter, angioplasty, peripheral, transluminal
Regulation Description	Percutaneous catheter.
Product Code	LIT
Regulation Number	870.1250
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ABBOTT VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
BIOTRONIK, INC.
	SUBSTANTIALLY EQUIVALENT	4
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BROSMED MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONTEGO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CORDIS US CORP
	SUBSTANTIALLY EQUIVALENT	1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
	SUBSTANTIALLY EQUIVALENT	1
1. K211044 Sublime Radial Access 018 RX Dilatation Catheter
CREAGH MEDICAL LTD. DBA SURMODICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CREAGH MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DK MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NATEC MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	3
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
QUALIMED USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
SILK ROAD MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUMMA THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	1
SUMMA THERAPEUTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	6702	6709
Burst Container or Vessel	1436	1436
Difficult to Remove	723	727
Leak/Splash	655	656
Detachment of Device or Device Component	580	582
Break	397	400
Adverse Event Without Identified Device or Use Problem	364	366
Deflation Problem	333	334
Inflation Problem	325	325
Material Deformation	263	264
Material Separation	250	250
Difficult to Advance	215	215
Entrapment of Device	136	136
Improper or Incorrect Procedure or Method	136	137
Material Split, Cut or Torn	134	134
Failure to Advance	131	131
Fluid/Blood Leak	96	96
Material Puncture/Hole	95	95
Device-Device Incompatibility	85	85
Fracture	83	83
Material Integrity Problem	76	76
Material Twisted/Bent	70	70
Stretched	60	60
Difficult to Insert	48	48
Difficult to Open or Remove Packaging Material	44	45
Failure to Deflate	43	43
Material Frayed	38	38
Device Dislodged or Dislocated	34	35
Device Contamination with Chemical or Other Material	32	32
Off-Label Use	31	31
Partial Blockage	28	28
Deformation Due to Compressive Stress	26	26
Use of Device Problem	24	24
Device Damaged Prior to Use	22	22
Crack	20	20
Failure to Fold	20	20
Retraction Problem	19	19
Device Markings/Labelling Problem	18	19
Material Fragmentation	18	18
Device Damaged by Another Device	15	15
Component Missing	15	16
Tear, Rip or Hole in Device Packaging	14	14
Packaging Problem	13	13
Device Contaminated During Manufacture or Shipping	13	13
Defective Component	10	10
Contamination	10	10
Physical Resistance/Sticking	10	10
Peeled/Delaminated	9	9
Loss of or Failure to Bond	9	9
Patient-Device Incompatibility	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10099	10114
Foreign Body In Patient	205	205
Insufficient Information	191	192
Vascular Dissection	155	155
No Consequences Or Impact To Patient	88	88
Perforation of Vessels	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	52	52
Embolism/Embolus	51	52
Hemorrhage/Bleeding	44	44
Device Embedded In Tissue or Plaque	43	43
Obstruction/Occlusion	41	41
Thrombosis/Thrombus	38	38
Stenosis	36	36
Hematoma	33	33
Restenosis	32	32
Pain	24	24
Unspecified Tissue Injury	22	22
Pseudoaneurysm	11	11
Stroke/CVA	10	10
Fistula	8	8
Extravasation	8	8
Unspecified Infection	8	8
Perforation	8	8
Vasoconstriction	7	7
Sepsis	7	7
Swelling/ Edema	6	6
Aneurysm	5	5
Rupture	5	5
Renal Failure	5	5
Ischemia	5	5
High Blood Pressure/ Hypertension	4	4
Myocardial Infarction	4	4
Arrhythmia	4	4
Calcium Deposits/Calcification	4	4
Cardiac Arrest	3	3
Pulmonary Embolism	3	3
Low Blood Pressure/ Hypotension	3	3
Vomiting	3	3
Numbness	3	3
Shock	3	3
Necrosis	3	3
Bradycardia	3	3
Hypoxia	2	2
Nausea	2	2
Arteriosclerosis/ Atherosclerosis	2	2
Tachycardia	2	2
Asystole	2	2
Unspecified Vascular Problem	2	2
Diarrhea	2	2
Post Operative Wound Infection	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jan-09-2026
2	Cordis Corporation	II	Aug-09-2021
3	Covidien LP	II	Oct-29-2024
4	Covidien Llc	II	Feb-03-2022
5	Ostial Corporation	II	Aug-17-2021
6	SUMMA THERAPEUTICS, LLC	II	Mar-30-2026
7	ev3 Inc	II	Jan-15-2025