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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	508	1245
Fracture	130	130
Detachment of Device or Device Component	113	114
Physical Resistance/Sticking	101	227
Positioning Problem	101	101
Device-Device Incompatibility	93	96
Material Separation	89	89
Defective Device	81	82
Difficult to Remove	80	82
Difficult to Advance	79	80
Material Deformation	57	60
Break	56	183
Material Perforation	35	35
Entrapment of Device	33	33
Material Integrity Problem	28	29
Display or Visual Feedback Problem	17	17
Nonstandard Device	17	17
Mechanical Problem	13	13
Unraveled Material	13	13
Material Frayed	11	11
Positioning Failure	11	11
Material Split, Cut or Torn	10	10
Failure to Advance	9	9
Sharp Edges	9	9
Component or Accessory Incompatibility	9	9
Fluid/Blood Leak	8	8
Deformation Due to Compressive Stress	8	8
Insufficient Information	7	7
Loss of or Failure to Bond	7	7
Device Contaminated During Manufacture or Shipping	7	7
Use of Device Problem	7	7
Device Contamination with Chemical or Other Material	7	7
Material Twisted/Bent	7	7
Device Damaged by Another Device	6	6
Material Fragmentation	5	5
Stretched	5	5
Failure to Cut	5	127
Difficult to Open or Remove Packaging Material	5	5
Mechanical Jam	4	370
Leak/Splash	4	4
Air/Gas in Device	4	4
Difficult to Insert	4	5
Device Dislodged or Dislocated	4	4
Migration	4	4
Inadequacy of Device Shape and/or Size	4	4
Delivered as Unsterile Product	4	4
Packaging Problem	4	4
Unintended Movement	3	3
Unsealed Device Packaging	3	3
Material Puncture/Hole	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	515	1132
Pericardial Effusion	258	505
Low Blood Pressure/ Hypotension	169	169
Foreign Body In Patient	129	255
Cardiac Perforation	110	112
Great Vessel Perforation	107	351
Cardiac Tamponade	104	106
Perforation of Vessels	92	702
Thrombosis/Thrombus	85	86
Hemorrhage/Bleeding	45	45
Air Embolism	31	31
Cardiac Arrest	29	29
Hematoma	29	29
Device Embedded In Tissue or Plaque	28	28
Non specific EKG/ECG Changes	26	26
Perforation	25	25
Insufficient Information	25	26
Vascular Dissection	20	20
Arrhythmia	16	16
Laceration(s)	11	11
Bradycardia	10	10
Unspecified Infection	10	10
Asystole	10	10
Heart Block	9	9
Pain	8	9
Tachycardia	7	7
Pleural Effusion	7	7
Retroperitoneal Hemorrhage	7	7
Unspecified Tissue Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Ischemia	6	6
Pseudoaneurysm	6	6
Myocardial Infarction	5	5
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Pneumothorax	4	4
Ventricular Fibrillation	4	4
Fistula	4	4
Stroke/CVA	4	4
Chest Pain	3	3
Pulmonary Embolism	3	3
Infiltration into Tissue	3	3
Hypoxia	3	3
Hemothorax	3	3
Rupture	3	3
Iatrogenic Source	3	125
Diminished Pulse Pressure	3	3
Obstruction/Occlusion	3	3
Thromboembolism	2	2
High Blood Pressure/ Hypertension	2	2
Vomiting	2	2