TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNAPTIC MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	264	268
Fracture	25	25
Difficult to Insert	23	24
Break	15	15
Insufficient Information	11	11
Gas/Air Leak	11	11
Unintended Movement	9	9
Material Twisted/Bent	9	9
Material Separation	8	8
Device Contamination with Body Fluid	6	6
Improper or Incorrect Procedure or Method	5	5
Physical Resistance/Sticking	5	5
Detachment of Device or Device Component	4	4
Material Puncture/Hole	4	4
Positioning Problem	4	4
Corroded	3	3
No Apparent Adverse Event	3	3
Difficult to Advance	3	3
Patient Device Interaction Problem	3	3
Device Contamination with Chemical or Other Material	2	2
Device Damaged by Another Device	2	2
Obstruction of Flow	2	2
Difficult to Remove	2	2
Output Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Fragmentation	1	1
Component Missing	1	1
Scratched Material	1	1
Contamination /Decontamination Problem	1	1
Particulates	1	1
Structural Problem	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Inadequacy of Device Shape and/or Size	1	1
Malposition of Device	1	1
Off-Label Use	1	1
Material Protrusion/Extrusion	1	1
Entrapment of Device	1	1
Compatibility Problem	1	1
Device-Device Incompatibility	1	1
Failure to Disconnect	1	1
Fluid/Blood Leak	1	1
Dull, Blunt	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	206	210
No Clinical Signs, Symptoms or Conditions	111	111
Pericardial Effusion	48	48
Cardiac Tamponade	35	35
Low Blood Pressure/ Hypotension	24	24
Thrombosis/Thrombus	10	10
Great Vessel Perforation	9	9
Hemorrhage/Bleeding	7	7
Perforation	7	7
Insufficient Information	7	7
Arrhythmia	6	6
Stroke/CVA	5	5
Foreign Body In Patient	5	5
Pseudoaneurysm	4	4
Hematoma	4	4
Needle Stick/Puncture	4	4
Asystole	3	3
Cardiac Arrest	3	3
Fistula	2	2
Perforation of Vessels	2	2
Unspecified Tissue Injury	2	2
Bradycardia	2	2
Transient Ischemic Attack	2	2
Vascular Dissection	2	2
Air Embolism	2	2
Non specific EKG/ECG Changes	2	2
Unspecified Mental, Emotional or Behavioural Problem	1	1
Foreign Body Embolism	1	1
Ventricular Fibrillation	1	1
Chest Pain	1	1
Discomfort	1	1
Scar Tissue	1	1
Atrial Fibrillation	1	1
Heart Failure/Congestive Heart Failure	1	1
Embolism/Embolus	1	1
Dizziness	1	1
Myocardial Infarction	1	1
Hypoxia	1	1
Hypersensitivity/Allergic reaction	1	1
No Consequences Or Impact To Patient	1	1
Unspecified Vascular Problem	1	1
Superficial (First Degree) Burn	1	1
Low Oxygen Saturation	1	1
Device Embedded In Tissue or Plaque	1	1