TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	3
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	438	438
Break	68	68
Difficult to Insert	29	29
Fracture	27	27
Activation, Positioning or Separation Problem	26	26
Material Separation	12	12
Gas/Air Leak	11	11
Insufficient Information	11	11
Detachment of Device or Device Component	9	9
Material Twisted/Bent	9	9
Unintended Movement	9	9
Physical Resistance/Sticking	6	6
Device Contamination with Body Fluid	6	6
Contamination /Decontamination Problem	5	5
Difficult to Advance	4	4
Positioning Problem	4	4
Improper or Incorrect Procedure or Method	4	4
No Apparent Adverse Event	4	4
Material Puncture/Hole	3	3
Corroded	3	3
Patient Device Interaction Problem	3	3
Material Fragmentation	3	3
Device Contamination with Chemical or Other Material	3	3
Failure to Advance	2	2
Defective Device	2	2
Difficult to Remove	2	2
Scratched Material	2	2
Use of Device Problem	2	2
Component Missing	2	2
Obstruction of Flow	2	2
Device Contaminated During Manufacture or Shipping	2	2
Device Damaged by Another Device	2	2
Material Protrusion/Extrusion	2	2
Appropriate Term/Code Not Available	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Component Misassembled	1	1
Failure to Disconnect	1	1
Dull, Blunt	1	1
Noise, Audible	1	1
Tear, Rip or Hole in Device Packaging	1	1
Inadequacy of Device Shape and/or Size	1	1
Partial Blockage	1	1
Delivered as Unsterile Product	1	1
Bent	1	1
Structural Problem	1	1
Particulates	1	1
Contamination	1	1
Expiration Date Error	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	347	347
No Clinical Signs, Symptoms or Conditions	112	112
Pericardial Effusion	53	53
No Known Impact Or Consequence To Patient	49	49
Cardiac Tamponade	40	40
Low Blood Pressure/ Hypotension	25	25
No Consequences Or Impact To Patient	22	22
Death	15	15
Stroke/CVA	12	12
Great Vessel Perforation	11	11
Perforation	10	10
Thrombosis/Thrombus	10	10
No Patient Involvement	9	9
Arrhythmia	8	8
Hemorrhage/Bleeding	8	8
Foreign Body In Patient	7	7
Pseudoaneurysm	5	5
Needle Stick/Puncture	5	5
Insufficient Information	5	5
Air Embolism	4	4
Vascular Dissection	4	4
Hematoma	4	4
Transient Ischemic Attack	4	4
No Code Available	3	3
Cardiac Arrest	3	3
Device Embedded In Tissue or Plaque	2	2
Fistula	2	2
Thrombus	2	2
Hemothorax	2	2
Unspecified Tissue Injury	2	2
Bradycardia	2	2
Pain	2	2
Aortic Dissection	2	2
Non specific EKG/ECG Changes	2	2
Discomfort	1	1
Chest Pain	1	1
Foreign Body Embolism	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Ventricular Fibrillation	1	1
Scar Tissue	1	1
Asystole	1	1
Heart Failure/Congestive Heart Failure	1	1
Extravasation	1	1
Pulmonary Edema	1	1
Perforation of Vessels	1	1
Sudden Cardiac Death	1	1
Blood Loss	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Edema	1	1