TPLC - Total Product Life Cycle

show TPLC since

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	318	318
Break	31	31
Difficult to Insert	28	28
Fracture	27	27
Insufficient Information	11	11
Gas/Air Leak	11	11
Unintended Movement	9	9
Material Twisted/Bent	9	9
Material Separation	8	8
Detachment of Device or Device Component	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
Positioning Problem	4	4
Corroded	3	3
Material Puncture/Hole	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
Component Missing	2	2
Obstruction of Flow	2	2
Material Protrusion/Extrusion	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
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	250	250
No Clinical Signs, Symptoms or Conditions	112	112
Pericardial Effusion	44	44
Cardiac Tamponade	35	35
Low Blood Pressure/ Hypotension	24	24
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	7	7
Stroke/CVA	7	7
Perforation	7	7
Death	6	6
Foreign Body In Patient	6	6
Pseudoaneurysm	5	5
Insufficient Information	5	5
Transient Ischemic Attack	4	4
Needle Stick/Puncture	4	4
Hematoma	4	4
Vascular Dissection	4	4
Air Embolism	3	3
Cardiac Arrest	2	2
Bradycardia	2	2
Unspecified Tissue Injury	2	2
Non specific EKG/ECG Changes	2	2
Thrombus	2	2
Fistula	2	2
Edema	1	1
Atrial Fibrillation	1	1
Embolism/Embolus	1	1
Ventricular Fibrillation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Dizziness	1	1
Chest Pain	1	1
Discomfort	1	1
Foreign Body Embolism	1	1
No Code Available	1	1
Pain	1	1
Scar Tissue	1	1
Asystole	1	1
Heart Failure/Congestive Heart Failure	1	1
Perforation of Vessels	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