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	594	1331
Fracture	136	136
Detachment of Device or Device Component	119	120
Physical Resistance/Sticking	103	229
Positioning Problem	100	100
Device-Device Incompatibility	95	98
Difficult to Advance	85	86
Material Separation	82	82
Defective Device	81	82
Difficult to Remove	76	78
Material Deformation	58	61
Material Perforation	39	39
Break	38	165
Packaging Problem	32	32
Material Integrity Problem	31	32
Entrapment of Device	30	30
Nonstandard Device	28	28
Positioning Failure	21	21
Display or Visual Feedback Problem	17	17
Deformation Due to Compressive Stress	13	13
Mechanical Problem	13	13
Unraveled Material	11	11
Device Contamination with Chemical or Other Material	10	10
Material Split, Cut or Torn	10	10
Material Frayed	10	10
Sharp Edges	9	9
Device Sensing Problem	9	9
Component or Accessory Incompatibility	9	9
Failure to Advance	8	8
Fluid/Blood Leak	7	7
Loss of or Failure to Bond	7	7
Device Contaminated During Manufacture or Shipping	7	7
Difficult to Insert	7	8
Insufficient Device Problem Information	7	7
Delivered as Unsterile Product	6	6
Device Damaged by Another Device	6	6
Use of Device Problem	6	6
Stretched	6	6
Off-Label Use	6	6
Difficult to Open or Remove Packaging Material	6	6
Material Twisted/Bent	5	5
Mechanical Jam	5	371
Failure to Cut	4	126
Inadequacy of Device Shape and/or Size	4	4
Unsealed Device Packaging	4	4
Air/Gas in Device	4	4
Tear, Rip or Hole in Device Packaging	3	3
Mechanics Altered	3	125
Material Puncture/Hole	3	3
Failure to Deliver Energy	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	598	1215
Pericardial Effusion	295	542
Low Blood Pressure/ Hypotension	190	190
Foreign Body In Patient	141	267
Cardiac Perforation	132	134
Cardiac Tamponade	125	127
Great Vessel Perforation	118	362
Perforation of Vessels	104	714
Thrombosis/Thrombus	89	90
Hemorrhage/Blood Loss/Bleeding	56	56
Hematoma	39	39
Air Embolism	35	35
Cardiac Arrest	32	32
Non specific EKG/ECG Changes	30	30
Device Embedded In Tissue or Plaque	29	29
Insufficient Information	28	29
Perforation	28	28
Vascular Dissection	23	23
Arrhythmia	19	19
Tachycardia	15	15
Heart Block	11	11
Laceration(s)	11	11
Asystole	11	11
Unspecified Infection	10	10
Bradycardia	10	10
Pain	8	9
Tricuspid Valve Insufficiency/ Regurgitation	8	8
Stroke/CVA	8	8
Pleural Effusion	8	8
Pseudoaneurysm	7	7
Unspecified Tissue Injury	7	7
Retroperitoneal Hemorrhage	7	7
Ischemia	6	6
Myocardial Infarction	6	6
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	6
Pneumothorax	5	5
Obstruction/Occlusion	5	5
Ventricular Fibrillation	5	5
Hypoxia	5	5
Pulmonary Embolism	4	4
Rupture	4	4
Heart Failure/Congestive Heart Failure	4	4
Fistula	4	4
Sepsis	4	4
Electric Shock	3	3
Diminished Pulse Pressure	3	3
Chest Pain	3	3
Hemothorax	3	3
Vomiting	3	3
Infiltration into Tissue	3	3