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 VASCULAR
	SUBSTANTIALLY EQUIVALENT	1
BIOTRONIK, INC.
	SUBSTANTIALLY EQUIVALENT	4
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
BROSMED MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CONTEGO MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
CORDIS US CORP.
	SUBSTANTIALLY EQUIVALENT	1
CREAGH MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
CREAGH MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
CREAGH MEDICAL LTD. (A WHOLLY OWNED SUBSIDIARY OF SURMODICS,
	SUBSTANTIALLY EQUIVALENT	1
CREAGH MEDICAL LTD. DBA SURMODICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DK MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INFINITY ANGIOPLASTY BALLOON COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	1
KOSSEL MEDTECH (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KOSSEL MEDTECH (SUZHOU) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC VASCULAR,INC(FORMERLY D.B.A EV3 INC.,COVIDIEN LLC)
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NATEC MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
NEXSTEP MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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	7695	7695
Burst Container or Vessel	1716	1716
Leak/Splash	745	745
Difficult to Remove	745	745
Detachment of Device or Device Component	669	669
Break	430	431
Adverse Event Without Identified Device or Use Problem	372	372
Inflation Problem	351	351
Deflation Problem	339	339
Material Separation	291	291
Material Deformation	290	290
Difficult to Advance	213	213
Failure to Advance	147	147
Improper or Incorrect Procedure or Method	141	141
Material Split, Cut or Torn	134	134
Entrapment of Device	134	134
Material Twisted/Bent	101	101
Material Puncture/Hole	101	101
Device-Device Incompatibility	87	87
Fracture	85	85
Fluid/Blood Leak	82	82
Material Integrity Problem	81	81
Stretched	63	63
Retraction Problem	51	51
Difficult to Insert	48	48
Difficult to Open or Remove Packaging Material	44	44
Off-Label Use	42	42
Device Dislodged or Dislocated	41	41
Failure to Deflate	40	40
Material Frayed	38	38
Use of Device Problem	37	37
Device Contamination with Chemical or Other Material	30	30
Device Damaged Prior to Use	27	27
Partial Blockage	27	27
Device Markings/Labelling Problem	26	26
Packaging Problem	25	25
Deformation Due to Compressive Stress	22	22
Crack	21	21
Failure to Fold	21	21
Device Damaged by Another Device	21	21
Device Handling Problem	19	19
Component Missing	17	17
Peeled/Delaminated	15	15
Material Fragmentation	15	15
Tear, Rip or Hole in Device Packaging	14	14
Device Contaminated During Manufacture or Shipping	13	13
Physical Resistance/Sticking	10	10
Defective Component	10	10
Mechanical Jam	10	10
Structural Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9429	9429
No Consequences Or Impact To Patient	2159	2159
Foreign Body In Patient	199	199
Insufficient Information	195	196
Vascular Dissection	166	166
Device Embedded In Tissue or Plaque	63	63
Perforation of Vessels	58	58
No Patient Involvement	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	56	56
Embolism/Embolus	49	49
Hemorrhage/Bleeding	48	48
Stenosis	45	45
Obstruction/Occlusion	45	45
Thrombosis/Thrombus	41	41
Hematoma	40	40
No Known Impact Or Consequence To Patient	35	35
Restenosis	31	31
Pain	26	26
Injury	23	23
Unspecified Tissue Injury	22	22
No Code Available	18	18
Stroke/CVA	12	12
Pseudoaneurysm	12	12
Unspecified Infection	10	10
Great Vessel Perforation	10	10
Extravasation	9	9
Perforation	9	9
Vasoconstriction	9	9
Fistula	8	8
Embolism	8	8
Swelling/ Edema	7	7
Sepsis	7	7
Calcium Deposits/Calcification	6	6
Myocardial Infarction	6	6
Rupture	6	6
Aneurysm	5	5
Occlusion	5	5
Renal Failure	5	5
Needle Stick/Puncture	5	5
Ischemia	5	5
Arrhythmia	5	5
No Information	4	4
Thrombosis	4	4
Low Blood Pressure/ Hypotension	4	4
Thrombus	4	4
Intimal Dissection	4	4
Pulmonary Embolism	4	4
High Blood Pressure/ Hypertension	4	4
Vomiting	3	3
Numbness	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Jan-30-2020
2	Cordis Corporation	II	Aug-09-2021
3	Cordis Corporation	II	Feb-28-2020
4	Covidien LP	II	Oct-29-2024
5	Covidien Llc	II	Feb-03-2022
6	Ostial Corporation	II	Aug-17-2021
7	ev3 Inc	II	Jan-15-2025
8	ev3 Inc.	II	Sep-30-2020