TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
	SUBSTANTIALLY EQUIVALENT	2
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	292
Break	31	31
Difficult to Insert	28	28
Fracture	26	26
Insufficient Information	11	11
Gas/Air Leak	11	11
Unintended Movement	9	9
Material Twisted/Bent	9	9
Detachment of Device or Device Component	7	7
Material Separation	7	7
Device Contamination with Body Fluid	6	6
Physical Resistance/Sticking	5	5
Improper or Incorrect Procedure or Method	4	4
Difficult to Advance	4	4
Corroded	3	3
Positioning Problem	3	3
Patient Device Interaction Problem	3	3
No Apparent Adverse Event	3	3
Device Contaminated During Manufacture or Shipping	2	2
Difficult to Remove	2	2
Contamination /Decontamination Problem	2	2
Material Protrusion/Extrusion	2	2
Component Missing	2	2
Obstruction of Flow	2	2
Device Contamination with Chemical or Other Material	2	2
Device Damaged by Another Device	2	2
Noise, Audible	1	1
Dull, Blunt	1	1
Failure to Disconnect	1	1
Appropriate Term/Code Not Available	1	1
Failure to Advance	1	1
Component Misassembled	1	1
Inadequacy of Device Shape and/or Size	1	1
Structural Problem	1	1
Particulates	1	1
Use of Device Problem	1	1
Material Fragmentation	1	1
Scratched Material	1	1
Contamination	1	1
Defective Device	1	1
Material Puncture/Hole	1	1
Malposition of Device	1	1
Off-Label Use	1	1
Entrapment of Device	1	1
Compatibility Problem	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	233	233
No Clinical Signs, Symptoms or Conditions	109	109
Pericardial Effusion	41	41
Cardiac Tamponade	28	28
Low Blood Pressure/ Hypotension	19	19
No Consequences Or Impact To Patient	14	14
No Known Impact Or Consequence To Patient	13	13
Thrombosis/Thrombus	10	10
Great Vessel Perforation	9	9
Hemorrhage/Bleeding	8	8
Arrhythmia	6	6
Stroke/CVA	6	6
Death	6	6
Foreign Body In Patient	6	6
Perforation	6	6
Insufficient Information	5	5
Pseudoaneurysm	4	4
Needle Stick/Puncture	4	4
Transient Ischemic Attack	4	4
Hematoma	4	4
Vascular Dissection	4	4
Air Embolism	3	3
Non specific EKG/ECG Changes	2	2
Thrombus	2	2
Cardiac Arrest	1	1
Edema	1	1
Ventricular Fibrillation	1	1
Atrial Fibrillation	1	1
Embolism/Embolus	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Chest Pain	1	1
Foreign Body Embolism	1	1
No Code Available	1	1
Pain	1	1
Scar Tissue	1	1
Bradycardia	1	1
Asystole	1	1
Heart Failure/Congestive Heart Failure	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Pneumothorax	1	1
Hypersensitivity/Allergic reaction	1	1
Superficial (First Degree) Burn	1	1
Atrial Perforation	1	1
Unspecified Vascular Problem	1	1
Hemothorax	1	1
ST Segment Elevation	1	1
Low Oxygen Saturation	1	1