TPLC - Total Product Life Cycle

show TPLC since

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	614	1351
Fracture	139	139
Detachment of Device or Device Component	127	128
Physical Resistance/Sticking	103	229
Positioning Problem	100	100
Device-Device Incompatibility	95	98
Difficult to Advance	90	91
Material Separation	82	82
Defective Device	81	82
Difficult to Remove	76	78
Material Deformation	59	62
Break	40	167
Material Perforation	39	39
Material Integrity Problem	33	34
Packaging Problem	32	32
Entrapment of Device	30	30
Nonstandard Device	29	29
Positioning Failure	28	28
Display or Visual Feedback Problem	17	17
Deformation Due to Compressive Stress	13	13
Mechanical Problem	13	13
Unraveled Material	12	12
Material Frayed	10	10
Material Split, Cut or Torn	10	10
Sharp Edges	10	10
Device Contamination with Chemical or Other Material	10	10
Device Sensing Problem	10	10
Fluid/Blood Leak	9	9
Component or Accessory Incompatibility	9	9
Difficult to Insert	9	10
Insufficient Device Problem Information	8	8
Failure to Advance	8	8
Off-Label Use	7	7
Device Contaminated During Manufacture or Shipping	7	7
Loss of or Failure to Bond	7	7
Stretched	6	6
Difficult to Open or Remove Packaging Material	6	6
Delivered as Unsterile Product	6	6
Use of Device Problem	6	6
Device Damaged by Another Device	6	6
Material Twisted/Bent	5	5
Mechanical Jam	5	371
Air/Gas in Device	4	4
Inadequacy of Device Shape and/or Size	4	4
Tear, Rip or Hole in Device Packaging	4	4
Unsealed Device Packaging	4	4
Failure to Cut	4	126
Migration	3	3
Mechanics Altered	3	125
Unintended Movement	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	610	1227
Pericardial Effusion	310	557
Low Blood Pressure/ Hypotension	199	199
Foreign Body In Patient	148	274
Cardiac Perforation	141	143
Cardiac Tamponade	132	134
Great Vessel Perforation	120	364
Perforation of Vessels	106	716
Thrombosis/Thrombus	90	91
Hemorrhage/Blood Loss/Bleeding	59	59
Hematoma	39	39
Air Embolism	35	35
Cardiac Arrest	32	32
Non specific EKG/ECG Changes	30	30
Device Embedded In Tissue or Plaque	30	30
Insufficient Information	30	31
Perforation	29	29
Vascular Dissection	23	23
Arrhythmia	19	19
Tachycardia	14	14
Laceration(s)	12	12
Asystole	11	11
Heart Block	11	11
Bradycardia	10	10
Stroke/CVA	10	10
Unspecified Infection	10	10
Tricuspid Valve Insufficiency/ Regurgitation	9	9
Pseudoaneurysm	8	8
Pleural Effusion	8	8
Pain	8	9
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
Hypoxia	5	5
Obstruction/Occlusion	5	5
Ventricular Fibrillation	5	5
Pneumothorax	5	5
Fistula	5	5
Rupture	4	4
Sepsis	4	4
Heart Failure/Congestive Heart Failure	4	4
Pulmonary Embolism	4	4
Diminished Pulse Pressure	3	3
Infiltration into Tissue	3	3
Atrial Fibrillation	3	3
Iatrogenic Source	3	125
Hemothorax	3	3
Electric Shock	3	3