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
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
WAVE MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	6908	6915
Burst Container or Vessel	1484	1484
Difficult to Remove	746	750
Leak/Splash	675	676
Detachment of Device or Device Component	597	599
Break	402	405
Adverse Event Without Identified Device or Use Problem	379	381
Deflation Problem	346	347
Inflation Problem	340	340
Material Deformation	270	271
Material Separation	258	258
Difficult to Advance	226	226
Entrapment of Device	144	144
Material Split, Cut or Torn	140	140
Improper or Incorrect Procedure or Method	139	140
Failure to Advance	133	133
Fluid/Blood Leak	104	104
Material Puncture/Hole	98	98
Device-Device Incompatibility	87	87
Fracture	86	86
Material Integrity Problem	76	76
Material Twisted/Bent	70	70
Stretched	60	60
Difficult to Insert	50	50
Difficult to Open or Remove Packaging Material	44	45
Failure to Deflate	43	43
Material Frayed	39	39
Device Dislodged or Dislocated	35	36
Device Contamination with Chemical or Other Material	34	34
Off-Label Use	32	32
Deformation Due to Compressive Stress	29	29
Partial Blockage	28	28
Use of Device Problem	27	27
Device Damaged Prior to Use	22	22
Crack	21	21
Failure to Fold	20	20
Material Fragmentation	20	20
Retraction Problem	19	19
Device Markings/Labelling Problem	18	19
Tear, Rip or Hole in Device Packaging	16	16
Component Missing	15	16
Device Damaged by Another Device	15	15
Device Contaminated During Manufacture or Shipping	14	14
Packaging Problem	13	13
Nonstandard Device	11	11
Contamination	11	11
Peeled/Delaminated	10	10
Defective Component	10	10
Physical Resistance/Sticking	10	10
Mechanical Jam	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10437	10452
Foreign Body In Patient	216	216
Insufficient Information	195	196
Vascular Dissection	156	156
No Consequences Or Impact To Patient	88	88
Perforation of Vessels	60	60
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	42	42
Thrombosis/Thrombus	41	41
Stenosis	36	36
Hematoma	33	33
Restenosis	32	32
Pain	24	24
Unspecified Tissue Injury	22	22
Pseudoaneurysm	11	11
Stroke/CVA	10	10
Perforation	9	9
Unspecified Infection	8	8
Fistula	8	8
Extravasation	8	8
Sepsis	7	7
Vasoconstriction	7	7
Swelling/ Edema	6	6
Aneurysm	5	5
Ischemia	5	5
Rupture	5	5
Renal Failure	5	5
Myocardial Infarction	4	4
Calcium Deposits/Calcification	4	4
High Blood Pressure/ Hypertension	4	4
Arrhythmia	4	4
Vomiting	3	3
Numbness	3	3
Pulmonary Embolism	3	3
Low Blood Pressure/ Hypotension	3	3
Bradycardia	3	3
Cardiac Arrest	3	3
Shock	3	3
Necrosis	3	3
Diarrhea	2	2
Post Operative Wound Infection	2	2
Unspecified Vascular Problem	2	2
Asystole	2	2
Transient Ischemic Attack	2	2
Tachycardia	2	2
Arteriosclerosis/ Atherosclerosis	2	2
Nausea	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