TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K212625 PathBuilder Transseptal Needle
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	296
Difficult to Insert	26	27
Fracture	25	25
Break	15	15
Gas/Air Leak	11	11
Insufficient Device Problem Information	11	11
Material Twisted/Bent	9	9
Unintended Movement	9	9
Material Separation	8	8
Improper or Incorrect Procedure or Method	7	7
Device Contamination with Body Fluid	6	6
Material Puncture/Hole	4	4
Detachment of Device or Device Component	4	4
Difficult to Advance	4	4
No Apparent Adverse Event	4	4
Corroded	3	3
Physical Resistance/Sticking	3	3
Patient Device Interaction Problem	3	3
Positioning Problem	3	3
Difficult to Remove	2	2
Obstruction of Flow	2	2
Fluid/Blood Leak	2	2
Device Contamination with Chemical or Other Material	2	2
Device Contaminated During Manufacture or Shipping	2	2
Malposition of Device	1	1
Failure to Disconnect	1	1
Structural Problem	1	1
Dull, Blunt	1	1
Component Missing	1	1
Noise, Audible	1	1
Material Protrusion/Extrusion	1	1
Compatibility Problem	1	1
Device-Device Incompatibility	1	1
Contamination /Decontamination Problem	1	1
Patient-Device Incompatibility	1	1
Material Fragmentation	1	1
Positioning Failure	1	1
Contamination	1	1
Inadequacy of Device Shape and/or Size	1	1
Off-Label Use	1	1
Unsealed Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	232	236
No Clinical Signs, Symptoms or Conditions	117	117
Pericardial Effusion	51	51
Cardiac Tamponade	37	37
Low Blood Pressure/ Hypotension	27	27
Great Vessel Perforation	13	13
Thrombosis/Thrombus	10	10
Perforation	9	9
Hemorrhage/Blood Loss/Bleeding	8	8
Arrhythmia	7	7
Insufficient Information	7	7
Stroke/CVA	5	5
Foreign Body In Patient	5	5
Hematoma	4	4
Asystole	4	4
Cardiac Arrest	4	4
Pseudoaneurysm	4	4
Needle Stick/Puncture	4	4
Vascular Dissection	2	2
Transient Ischemic Attack	2	2
Bradycardia	2	2
Air Embolism	2	2
Non specific EKG/ECG Changes	2	2
Fistula	2	2
Unspecified Tissue Injury	2	2
Perforation of Vessels	2	2
Hypoxia	1	1
Embolism/Embolus	1	1
Cognitive Changes	1	1
Scar Tissue	1	1
Low Oxygen Saturation	1	1
Respiratory Arrest	1	1
Ventricular Fibrillation	1	1
No Consequences Or Impact To Patient	1	1
Myocardial Infarction	1	1
Superficial (First Degree) Burn	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Foreign Body Embolism	1	1
Hypersensitivity/Allergic reaction	1	1
Heart Failure/Congestive Heart Failure	1	1
Dizziness	1	1
Unspecified Vascular Problem	1	1
Discomfort	1	1
Device Embedded In Tissue or Plaque	1	1
Diplopia/Double Vision	1	1
Chest Pain	1	1
Atrial Fibrillation	1	1