TPLC - Total Product Life Cycle

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Device	dilator, vessel, for percutaneous catheterization
Regulation Description	Vessel dilator for percutaneous catheterization.
Product Code	DRE
Regulation Number	870.1310
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAYLIS MEDICAL COMPANY, INC.
	SUBSTANTIALLY EQUIVALENT	3
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
1. K212784 TightRail Guardian Motorized Dilator Sheath
2. K223472 TightRail Guardian Motorized Dilator Sheath, 9 Fre ...
XCARDIA INNOVATION , LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	522	1259
Fracture	132	132
Detachment of Device or Device Component	114	115
Physical Resistance/Sticking	103	229
Positioning Problem	101	101
Device-Device Incompatibility	93	96
Material Separation	89	89
Defective Device	81	82
Difficult to Advance	81	82
Difficult to Remove	80	82
Material Deformation	57	60
Break	57	184
Material Perforation	36	36
Entrapment of Device	35	35
Material Integrity Problem	32	33
Nonstandard Device	18	18
Display or Visual Feedback Problem	17	17
Unraveled Material	13	13
Mechanical Problem	13	13
Failure to Advance	12	12
Positioning Failure	12	12
Material Frayed	11	11
Deformation Due to Compressive Stress	10	10
Material Split, Cut or Torn	10	10
Sharp Edges	9	9
Component or Accessory Incompatibility	9	9
Device Contamination with Chemical or Other Material	8	8
Fluid/Blood Leak	8	8
Insufficient Information	7	7
Loss of or Failure to Bond	7	7
Device Contaminated During Manufacture or Shipping	7	7
Material Twisted/Bent	7	7
Use of Device Problem	7	7
Device Damaged by Another Device	6	6
Difficult to Open or Remove Packaging Material	5	5
Material Fragmentation	5	5
Difficult to Insert	5	6
Stretched	5	5
Failure to Cut	5	127
Migration	4	4
Device Sensing Problem	4	4
Device Dislodged or Dislocated	4	4
Inadequacy of Device Shape and/or Size	4	4
Packaging Problem	4	4
Mechanical Jam	4	370
Delivered as Unsterile Product	4	4
Air/Gas in Device	4	4
Off-Label Use	4	4
Leak/Splash	4	4
Material Too Rigid or Stiff	3	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	526	1143
Pericardial Effusion	267	514
Low Blood Pressure/ Hypotension	173	173
Foreign Body In Patient	132	258
Cardiac Perforation	113	115
Great Vessel Perforation	110	354
Cardiac Tamponade	108	110
Perforation of Vessels	97	707
Thrombosis/Thrombus	88	89
Hemorrhage/Bleeding	46	46
Air Embolism	32	32
Hematoma	30	30
Device Embedded In Tissue or Plaque	29	29
Cardiac Arrest	29	29
Non specific EKG/ECG Changes	27	27
Perforation	26	26
Insufficient Information	25	26
Vascular Dissection	20	20
Arrhythmia	17	17
Laceration(s)	11	11
Unspecified Infection	10	10
Asystole	10	10
Bradycardia	10	10
Heart Block	10	10
Pain	8	9
Tachycardia	8	8
Pleural Effusion	7	7
Retroperitoneal Hemorrhage	7	7
Ischemia	6	6
Unspecified Tissue Injury	6	6
Pseudoaneurysm	6	6
Myocardial Infarction	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Stroke/CVA	4	4
Ventricular Fibrillation	4	4
Pneumothorax	4	4
Fistula	4	4
Diminished Pulse Pressure	3	3
Obstruction/Occlusion	3	3
Rupture	3	3
Iatrogenic Source	3	125
Hypoxia	3	3
Infiltration into Tissue	3	3
Hemothorax	3	3
Pulmonary Embolism	3	3
Chest Pain	3	3
Swelling/ Edema	2	2
Calcium Deposits/Calcification	2	2
Cough	2	2