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	324	324
Break	50	50
Difficult to Insert	27	27
Fracture	22	22
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	8	8
Material Twisted/Bent	8	8
Device Contamination with Body Fluid	5	5
Contamination /Decontamination Problem	5	5
Difficult to Advance	4	4
Improper or Incorrect Procedure or Method	3	3
Corroded	3	3
No Apparent Adverse Event	3	3
Patient Device Interaction Problem	3	3
Positioning Problem	3	3
Physical Resistance/Sticking	3	3
Difficult to Remove	2	2
Material Fragmentation	2	2
Component Missing	2	2
Device Contamination with Chemical or Other Material	2	2
Material Protrusion/Extrusion	2	2
Device Contaminated During Manufacture or Shipping	2	2
Scratched Material	1	1
Contamination	1	1
Use of Device Problem	1	1
Obstruction of Flow	1	1
Defective Device	1	1
Particulates	1	1
Structural Problem	1	1
Material Puncture/Hole	1	1
Delivered as Unsterile Product	1	1
Inadequacy of Device Shape and/or Size	1	1
Malposition of Device	1	1
Entrapment of Device	1	1
Component Misassembled	1	1
Failure to Advance	1	1
Appropriate Term/Code Not Available	1	1
Compatibility Problem	1	1
Flaked	1	1
Device-Device Incompatibility	1	1
Failure to Disconnect	1	1
Dull, Blunt	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	254	254
No Clinical Signs, Symptoms or Conditions	100	100
Pericardial Effusion	44	44
Cardiac Tamponade	29	29
No Known Impact Or Consequence To Patient	29	29
Low Blood Pressure/ Hypotension	19	19
No Consequences Or Impact To Patient	18	18
Death	12	12
Stroke/CVA	9	9
Great Vessel Perforation	9	9
Thrombosis/Thrombus	8	8
Perforation	7	7
Hemorrhage/Bleeding	7	7
Arrhythmia	6	6
Foreign Body In Patient	6	6
No Patient Involvement	6	6
Vascular Dissection	5	5
Insufficient Information	5	5
Hematoma	4	4
Transient Ischemic Attack	4	4
Air Embolism	3	3
Pseudoaneurysm	3	3
Non specific EKG/ECG Changes	2	2
Device Embedded In Tissue or Plaque	2	2
No Code Available	2	2
Thrombus	2	2
Hemothorax	2	2
Cardiac Arrest	2	2
Aortic Dissection	2	2
Needle Stick/Puncture	2	2
Pain	2	2
Fistula	1	1
Respiratory Failure	1	1
Low Oxygen Saturation	1	1
ST Segment Elevation	1	1
Unspecified Vascular Problem	1	1
Atrial Perforation	1	1
Myocardial Infarction	1	1
Hypoxia	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Pulmonary Edema	1	1
Extravasation	1	1
Heart Failure/Congestive Heart Failure	1	1
Asystole	1	1
Bradycardia	1	1
Scar Tissue	1	1
Foreign Body Embolism	1	1
Chest Pain	1	1
Ventricular Fibrillation	1	1