TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	3
1. K210328 SafeSept Blunt Needle
2. K221707 SafeSept® Transseptal Guidewire (SS-140)
3. K241042 SafeSharp Transseptal Needle (CLICK071, CLICK171, ...
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	296	300
Difficult to Insert	26	27
Fracture	25	25
Break	15	15
Insufficient Device Problem Information	11	11
Gas/Air Leak	11	11
Unintended Movement	9	9
Material Twisted/Bent	9	9
Material Separation	8	8
Improper or Incorrect Procedure or Method	7	7
Device Contamination with Body Fluid	6	6
No Apparent Adverse Event	4	4
Detachment of Device or Device Component	4	4
Material Puncture/Hole	4	4
Difficult to Advance	4	4
Corroded	3	3
Patient Device Interaction Problem	3	3
Positioning Problem	3	3
Physical Resistance/Sticking	3	3
Difficult to Remove	2	2
Obstruction of Flow	2	2
Device Contamination with Chemical or Other Material	2	2
Device Contaminated During Manufacture or Shipping	2	2
Fluid/Blood Leak	2	2
Dull, Blunt	2	2
Contamination /Decontamination Problem	1	1
Material Fragmentation	1	1
Positioning Failure	1	1
Component Missing	1	1
Contamination	1	1
Unsealed Device Packaging	1	1
Structural Problem	1	1
Patient-Device Incompatibility	1	1
Inadequacy of Device Shape and/or Size	1	1
Malposition of Device	1	1
Material Protrusion/Extrusion	1	1
Off-Label Use	1	1
Compatibility Problem	1	1
Device-Device Incompatibility	1	1
Failure to Disconnect	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	236	240
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
Pseudoaneurysm	4	4
Asystole	4	4
Hematoma	4	4
Cardiac Arrest	4	4
Needle Stick/Puncture	4	4
Fistula	2	2
Unspecified Tissue Injury	2	2
Perforation of Vessels	2	2
Bradycardia	2	2
Transient Ischemic Attack	2	2
Vascular Dissection	2	2
Non specific EKG/ECG Changes	2	2
Air Embolism	2	2
Ventricular Fibrillation	1	1
Diplopia/Double Vision	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Cognitive Changes	1	1
Chest Pain	1	1
Discomfort	1	1
Foreign Body Embolism	1	1
Atrial Fibrillation	1	1
Embolism/Embolus	1	1
Scar Tissue	1	1
Dizziness	1	1
Heart Failure/Congestive Heart Failure	1	1
Respiratory Arrest	1	1
Hypersensitivity/Allergic reaction	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Syncope/Fainting	1	1
Superficial (First Degree) Burn	1	1
No Consequences Or Impact To Patient	1	1
Unspecified Vascular Problem	1	1
Low Oxygen Saturation	1	1
Device Embedded In Tissue or Plaque	1	1