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	292	296
Difficult to Insert	26	27
Fracture	25	25
Break	15	15
Gas/Air Leak	11	11
Insufficient Device Problem Information	11	11
Material Twisted/Bent	9	9
Unintended Movement	9	9
Material Separation	8	8
Improper or Incorrect Procedure or Method	7	7
Device Contamination with Body Fluid	6	6
Difficult to Advance	4	4
No Apparent Adverse Event	4	4
Detachment of Device or Device Component	4	4
Material Puncture/Hole	4	4
Physical Resistance/Sticking	3	3
Corroded	3	3
Positioning Problem	3	3
Patient Device Interaction Problem	3	3
Obstruction of Flow	2	2
Fluid/Blood Leak	2	2
Difficult to Remove	2	2
Device Contaminated During Manufacture or Shipping	2	2
Device Contamination with Chemical or Other Material	2	2
Contamination /Decontamination Problem	1	1
Failure to Disconnect	1	1
Contamination	1	1
Off-Label Use	1	1
Component Missing	1	1
Noise, Audible	1	1
Patient-Device Incompatibility	1	1
Inadequacy of Device Shape and/or Size	1	1
Structural Problem	1	1
Malposition of Device	1	1
Compatibility Problem	1	1
Unsealed Device Packaging	1	1
Dull, Blunt	1	1
Device-Device Incompatibility	1	1
Material Fragmentation	1	1
Material Protrusion/Extrusion	1	1
Positioning Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	232	236
No Clinical Signs, Symptoms or Conditions	117	117
Pericardial Effusion	51	51
Cardiac Tamponade	37	37
Low Blood Pressure/ Hypotension	27	27
Great Vessel Perforation	13	13
Thrombosis/Thrombus	10	10
Perforation	9	9
Hemorrhage/Blood Loss/Bleeding	8	8
Arrhythmia	7	7
Insufficient Information	7	7
Stroke/CVA	5	5
Foreign Body In Patient	5	5
Hematoma	4	4
Asystole	4	4
Needle Stick/Puncture	4	4
Pseudoaneurysm	4	4
Cardiac Arrest	4	4
Perforation of Vessels	2	2
Transient Ischemic Attack	2	2
Unspecified Tissue Injury	2	2
Air Embolism	2	2
Vascular Dissection	2	2
Fistula	2	2
Bradycardia	2	2
Non specific EKG/ECG Changes	2	2
Hypoxia	1	1
Embolism/Embolus	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Scar Tissue	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
Chest Pain	1	1
Foreign Body Embolism	1	1
Myocardial Infarction	1	1
Superficial (First Degree) Burn	1	1
Cognitive Changes	1	1
No Consequences Or Impact To Patient	1	1
Low Oxygen Saturation	1	1
Heart Failure/Congestive Heart Failure	1	1
Device Embedded In Tissue or Plaque	1	1
Unspecified Vascular Problem	1	1
Diplopia/Double Vision	1	1
Dizziness	1	1
Atrial Fibrillation	1	1
Ventricular Fibrillation	1	1
Discomfort	1	1