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	552	1289
Fracture	137	137
Detachment of Device or Device Component	128	129
Physical Resistance/Sticking	107	233
Positioning Problem	101	101
Device-Device Incompatibility	94	97
Material Separation	89	89
Difficult to Advance	84	85
Difficult to Remove	82	84
Defective Device	82	83
Break	64	191
Material Deformation	57	60
Entrapment of Device	37	37
Material Perforation	37	37
Packaging Problem	33	33
Material Integrity Problem	31	32
Nonstandard Device	26	26
Positioning Failure	17	17
Display or Visual Feedback Problem	17	17
Unraveled Material	14	14
Mechanical Problem	13	13
Failure to Advance	12	12
Deformation Due to Compressive Stress	11	11
Material Split, Cut or Torn	11	11
Material Frayed	11	11
Sharp Edges	9	9
Component or Accessory Incompatibility	9	9
Device Contamination with Chemical or Other Material	9	9
Fluid/Blood Leak	9	9
Material Twisted/Bent	7	7
Insufficient Information	7	7
Use of Device Problem	7	7
Loss of or Failure to Bond	7	7
Device Contaminated During Manufacture or Shipping	7	7
Device Sensing Problem	7	7
Device Damaged by Another Device	6	6
Difficult to Open or Remove Packaging Material	6	6
Difficult to Insert	6	7
Stretched	6	6
Failure to Cut	5	127
Delivered as Unsterile Product	5	5
Material Fragmentation	5	5
Mechanical Jam	5	371
Air/Gas in Device	4	4
Migration	4	4
Inadequacy of Device Shape and/or Size	4	4
Device Dislodged or Dislocated	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	585	1202
Pericardial Effusion	283	530
Low Blood Pressure/ Hypotension	182	182
Foreign Body In Patient	140	266
Cardiac Perforation	125	127
Great Vessel Perforation	114	358
Cardiac Tamponade	114	116
Perforation of Vessels	102	712
Thrombosis/Thrombus	89	90
Hemorrhage/Bleeding	50	50
Air Embolism	33	33
Hematoma	32	32
Cardiac Arrest	31	31
Non specific EKG/ECG Changes	29	29
Device Embedded In Tissue or Plaque	29	29
Insufficient Information	27	28
Perforation	27	27
Vascular Dissection	20	20
Arrhythmia	18	18
Tachycardia	13	13
Asystole	11	11
Laceration(s)	11	11
Unspecified Infection	10	10
Heart Block	10	10
Bradycardia	10	10
Pain	8	9
Pseudoaneurysm	7	7
Pleural Effusion	7	7
Retroperitoneal Hemorrhage	7	7
Myocardial Infarction	6	6
Unspecified Tissue Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Ischemia	6	6
Obstruction/Occlusion	5	5
Stroke/CVA	5	5
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Fistula	4	4
Ventricular Fibrillation	4	4
Pneumothorax	4	4
Hypoxia	4	4
Rupture	3	3
Pulmonary Embolism	3	3
Hemothorax	3	3
Iatrogenic Source	3	125
Infiltration into Tissue	3	3
Diminished Pulse Pressure	3	3
Chest Pain	3	3
Electric Shock	3	3
Heart Failure/Congestive Heart Failure	3	3
Sepsis	3	3