TPLC - Total Product Life Cycle

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Device	catheter, percutaneous, cutting/scoring
Regulation Description	Percutaneous catheter.
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
BARD PERIPHERAL VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
BROSMED MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAGENT VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	2
DK MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
GOODMAN CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TRANSIT SCIENTIFIC, LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	1392	2980
Difficult to Remove	117	117
Leak/Splash	91	92
Detachment of Device or Device Component	78	78
Adverse Event Without Identified Device or Use Problem	75	76
Device-Device Incompatibility	59	59
Device Dislodged or Dislocated	44	44
Fluid/Blood Leak	38	38
Break	35	36
Material Deformation	35	35
Failure to Advance	23	23
Inflation Problem	23	23
Deflation Problem	22	144
Material Split, Cut or Torn	17	17
Entrapment of Device	17	139
Failure to Deflate	16	16
Insufficient Device Problem Information	15	15
Difficult to Insert	12	12
Difficult to Advance	11	11
Material Integrity Problem	10	10
Material Separation	9	9
Material Puncture/Hole	8	8
Improper or Incorrect Procedure or Method	6	6
Material Twisted/Bent	6	6
Burst Container or Vessel	5	5
Device Contamination with Chemical or Other Material	4	4
Nonstandard Device	3	3
Sharp Edges	3	3
Stretched	3	3
Crack	2	3
Deformation Due to Compressive Stress	2	3
Backflow	1	2
Device Misassembled During Manufacturing /Shipping	1	1
Air/Gas in Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Difficult to Flush	1	1
Device Damaged Prior to Use	1	1
Connection Problem	1	1
Peeled/Delaminated	1	1
Difficult to Open or Remove Packaging Material	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1729	3439
Foreign Body In Patient	11	11
Vascular Dissection	10	10
No Consequences Or Impact To Patient	10	10
Perforation of Vessels	7	7
Hemorrhage/Blood Loss/Bleeding	5	5
Restenosis	5	5
Hematoma	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Itching Sensation	2	2
Rash	2	2
Needle Stick/Puncture	2	2
Thrombosis/Thrombus	2	2
Insufficient Information	2	2
Laceration(s)	2	2
Stenosis	2	2
Pseudoaneurysm	2	2
Inflammation	1	1
Embolism/Embolus	1	1
Rupture	1	1
Obstruction/Occlusion	1	1
Pain	1	1
Failure to Anastomose	1	123
Bradycardia	1	1
Calcium Deposits/Calcification	1	1
Low Blood Pressure/ Hypotension	1	1
Fistula	1	1