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	1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	307	307
Break	48	48
Difficult to Insert	23	23
Fracture	13	13
Activation, Positioning or Separation Problem	12	12
Insufficient Information	11	11
Gas/Air Leak	10	10
Detachment of Device or Device Component	9	9
Unintended Movement	9	9
Material Separation	6	6
Contamination /Decontamination Problem	5	5
Difficult to Advance	4	4
Positioning Problem	3	3
Corroded	3	3
Device Contamination with Body Fluid	3	3
No Apparent Adverse Event	3	3
Patient Device Interaction Problem	3	3
Material Twisted/Bent	3	3
Physical Resistance/Sticking	3	3
Material Fragmentation	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Protrusion/Extrusion	2	2
Device Contamination with Chemical or Other Material	2	2
Difficult to Remove	2	2
Improper or Incorrect Procedure or Method	2	2
Component Missing	2	2
Inadequacy of Device Shape and/or Size	1	1
Use of Device Problem	1	1
Device-Device Incompatibility	1	1
Compatibility Problem	1	1
Scratched Material	1	1
Delivered as Unsterile Product	1	1
Particulates	1	1
Entrapment of Device	1	1
Flaked	1	1
Contamination	1	1
Dull, Blunt	1	1
Obstruction of Flow	1	1
Structural Problem	1	1
Failure to Advance	1	1
Failure to Disconnect	1	1
Defective Device	1	1
Malposition of Device	1	1
Component Misassembled	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	240	240
No Clinical Signs, Symptoms or Conditions	75	75
Pericardial Effusion	43	43
No Known Impact Or Consequence To Patient	29	29
Cardiac Tamponade	25	25
No Consequences Or Impact To Patient	18	18
Low Blood Pressure/ Hypotension	17	17
Death	12	12
Stroke/CVA	9	9
Great Vessel Perforation	8	8
Perforation	7	7
Thrombosis/Thrombus	7	7
No Patient Involvement	6	6
Foreign Body In Patient	6	6
Hemorrhage/Bleeding	6	6
Arrhythmia	5	5
Insufficient Information	5	5
Vascular Dissection	4	4
Transient Ischemic Attack	4	4
Hematoma	3	3
Pseudoaneurysm	3	3
Device Embedded In Tissue or Plaque	2	2
No Code Available	2	2
Pain	2	2
Thrombus	2	2
Aortic Dissection	2	2
Needle Stick/Puncture	2	2
Cardiac Arrest	2	2
Hemothorax	2	2
Hypersensitivity/Allergic reaction	1	1
Chest Pain	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Occlusion	1	1
Air Embolism	1	1
Atrial Fibrillation	1	1
Bradycardia	1	1
Non specific EKG/ECG Changes	1	1
Edema	1	1
Extravasation	1	1
Fistula	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Atrial Perforation	1	1
Ventricular Fibrillation	1	1
Perforation of Vessels	1	1
Pneumothorax	1	1
Pulmonary Edema	1	1
ST Segment Elevation	1	1
Blood Loss	1	1
Superficial (First Degree) Burn	1	1
Foreign Body Embolism	1	1
Unspecified Vascular Problem	1	1
Asystole	1	1
Unspecified Tissue Injury	1	1