TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	356	356
Failure to Advance	73	73
Difficult to Advance	58	58
Positioning Problem	45	45
Display or Visual Feedback Problem	41	41
Material Integrity Problem	29	29
Material Deformation	27	27
Detachment of Device or Device Component	19	19
Device-Device Incompatibility	15	15
Burst Container or Vessel	15	15
Use of Device Problem	15	15
Insufficient Information	15	15
Physical Resistance/Sticking	11	11
Material Frayed	7	7
Difficult to Remove	6	6
Defective Device	6	6
Break	5	5
Device Dislodged or Dislocated	5	5
Deformation Due to Compressive Stress	4	4
Leak/Splash	4	4
Device Displays Incorrect Message	4	4
Thermal Decomposition of Device	4	4
Deflation Problem	4	4
Contamination	4	4
Packaging Problem	3	3
Material Rupture	3	3
Obstruction of Flow	3	3
Unsealed Device Packaging	3	3
Unintended Movement	2	2
Difficult to Insert	2	2
Positioning Failure	2	2
Material Puncture/Hole	2	2
Device Markings/Labelling Problem	2	2
Difficult or Delayed Positioning	2	2
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
High impedance	2	2
Device Contaminated During Manufacture or Shipping	2	2
Failure to Deliver Energy	2	2
Patient-Device Incompatibility	1	1
Component Missing	1	1
Improper Flow or Infusion	1	1
Difficult to Open or Remove Packaging Material	1	1
Communication or Transmission Problem	1	1
Electromagnetic Compatibility Problem	1	1
Off-Label Use	1	1
Migration or Expulsion of Device	1	1
Failure to Fire	1	1
Mechanical Problem	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pericardial Effusion	284	284
No Clinical Signs, Symptoms or Conditions	158	158
Cardiac Tamponade	133	133
Low Blood Pressure/ Hypotension	126	126
Cardiac Perforation	87	87
Thrombosis/Thrombus	45	45
Perforation of Vessels	34	34
Perforation	32	32
Hematoma	29	29
Cardiac Arrest	20	20
Hemorrhage/Bleeding	19	19
No Consequences Or Impact To Patient	15	15
Air Embolism	11	11
Arrhythmia	11	11
Stroke/CVA	10	10
Chest Pain	9	9
Bradycardia	9	9
Tachycardia	8	8
Death	7	7
Non specific EKG/ECG Changes	6	6
Asystole	6	6
Insufficient Information	5	5
Dyspnea	5	5
Foreign Body In Patient	5	5
Hemothorax	5	5
Atrial Fibrillation	4	4
Embolism/Embolus	4	4
No Known Impact Or Consequence To Patient	4	4
Pseudoaneurysm	4	4
Respiratory Arrest	4	4
Ventricular Fibrillation	4	4
Heart Block	4	4
Fistula	4	4
High Blood Pressure/ Hypertension	4	4
Transient Ischemic Attack	3	3
Hypoxia	3	3
Burn(s)	3	3
Pleural Effusion	3	3
Swelling/ Edema	2	2
Shock	2	2
Embolism	2	2
Pain	2	2
Thromboembolism	2	2
Device Embedded In Tissue or Plaque	2	2
Needle Stick/Puncture	2	2
Intracranial Hemorrhage	2	2
Pericarditis	2	2
Diminished Pulse Pressure	2	2
Hemoptysis	2	2
Vascular Dissection	2	2