TPLC - Total Product Life Cycle

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Device	catheter, percutaneous, cutting/scoring
Definition	To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Product Code	PNO
Regulation Number	870.1250
Device Class	2

Premarket Reviews
Manufacturer	Decision
CAGENT VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	4
DK MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GOODMAN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORBUSNEICH MEDICAL TRADING, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRANSIT SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
TRANSIT SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	1
VENTUREMED GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	524	2110
Adverse Event Without Identified Device or Use Problem	83	83
Difficult to Remove	50	50
Detachment of Device or Device Component	44	44
Device-Device Incompatibility	37	37
Leak/Splash	30	30
Deflation Problem	28	150
Device Dislodged or Dislocated	23	23
Break	22	22
Failure to Advance	21	21
Material Deformation	17	17
Inflation Problem	14	14
Entrapment of Device	14	136
Improper or Incorrect Procedure or Method	12	12
Retraction Problem	10	10
Material Split, Cut or Torn	9	9
Difficult to Insert	6	6
Burst Container or Vessel	6	6
Difficult to Advance	6	6
Material Integrity Problem	5	5
Failure to Deflate	5	5
Material Separation	4	4
Material Twisted/Bent	3	3
Crack	2	2
Physical Resistance/Sticking	2	2
Sharp Edges	2	2
Air/Gas in Device	1	1
Backflow	1	1
Difficult to Flush	1	1
Fracture	1	1
Material Frayed	1	1
Poor Quality Image	1	1
Peeled/Delaminated	1	1
Off-Label Use	1	1
Material Puncture/Hole	1	1
Insufficient Information	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Contamination with Chemical or Other Material	1	1
Device Damaged Prior to Use	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Defective Device	1	1
Deformation Due to Compressive Stress	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	560	2268
No Consequences Or Impact To Patient	124	124
Vascular Dissection	52	52
Stenosis	22	22
Restenosis	11	11
Injury	7	7
Foreign Body In Patient	4	4
No Known Impact Or Consequence To Patient	4	4
Perforation of Vessels	4	4
Occlusion	4	4
Hematoma	3	3
Hemorrhage/Bleeding	3	3
Laceration(s)	2	2
Calcium Deposits/Calcification	2	2
Thrombosis/Thrombus	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Needle Stick/Puncture	2	2
Atrial Perforation	2	2
Pseudoaneurysm	1	1
No Code Available	1	1
Embolism/Embolus	1	1
Insufficient Information	1	1
Death	1	1
Embolism	1	1
Fistula	1	1
Failure to Anastomose	1	123
Inflammation	1	1
Reocclusion	1	1
Pain	1	1
Perforation	1	1
Complaint, Ill-Defined	1	1
Rupture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	I	Jun-17-2019