TPLC - Total Product Life Cycle

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Device	transducer, pressure, catheter tip
Regulation Description	Catheter tip pressure transducer.
Product Code	DXO
Regulation Number	870.2870
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACIST MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
1. K193279 Comet II Pressure Guidewire
EDWARDS LIFECIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
OPSENS, INC.
	SUBSTANTIALLY EQUIVALENT	5
ZURICH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	209	210
Incorrect, Inadequate or Imprecise Result or Readings	186	186
Communication or Transmission Problem	110	110
Material Separation	95	95
Incorrect Measurement	77	77
Break	69	69
Adverse Event Without Identified Device or Use Problem	63	63
Contamination	62	62
Difficult to Remove	54	54
Failure to Advance	50	50
Device Contamination with Chemical or Other Material	38	38
Fracture	36	36
Deformation Due to Compressive Stress	35	35
Fluid/Blood Leak	34	34
Difficult to Advance	32	32
Leak/Splash	28	28
Improper or Incorrect Procedure or Method	27	27
Failure to Zero	25	25
Material Deformation	21	21
Contamination /Decontamination Problem	20	20
Disconnection	19	19
Use of Device Problem	17	17
Material Integrity Problem	16	16
Peeled/Delaminated	14	14
Material Split, Cut or Torn	13	13
Entrapment of Device	13	13
Output Problem	12	12
Air/Gas in Device	12	12
Physical Resistance/Sticking	11	11
Inaccurate Flow Rate	11	11
Stretched	10	10
Obstruction of Flow	9	9
Loose or Intermittent Connection	9	9
Insufficient Information	9	9
Device Contaminated During Manufacture or Shipping	8	8
Mechanical Problem	8	8
Material Twisted/Bent	7	7
Defective Device	7	7
Unsealed Device Packaging	7	7
Calibration Problem	6	6
Material Frayed	5	5
Pacing Problem	5	5
Mechanical Jam	5	5
Appropriate Term/Code Not Available	5	5
Delivered as Unsterile Product	5	5
Failure to Clean Adequately	4	4
Positioning Problem	4	4
Nonstandard Device	4	4
Contamination of Device Ingredient or Reagent	3	3
Defective Component	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	675	676
No Consequences Or Impact To Patient	223	223
No Known Impact Or Consequence To Patient	129	129
Hemorrhage/Bleeding	37	37
Vascular Dissection	27	27
Insufficient Information	26	26
Device Embedded In Tissue or Plaque	22	22
No Patient Involvement	18	18
Foreign Body In Patient	17	17
Cerebrospinal Fluid Leakage	14	14
Air Embolism	12	12
Pericardial Effusion	10	10
No Code Available	9	9
Low Blood Pressure/ Hypotension	8	8
Burn(s)	8	8
Blood Loss	8	8
Embolism/Embolus	8	8
Loss of consciousness	7	7
Unspecified Infection	4	4
Obstruction/Occlusion	4	4
Myocardial Infarction	4	4
Cardiac Arrest	4	4
Vasoconstriction	3	3
High Blood Pressure/ Hypertension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Perforation of Vessels	3	3
Cardiac Tamponade	3	3
Ventricular Fibrillation	3	3
Full thickness (Third Degree) Burn	2	2
Ischemia Stroke	2	2
Partial thickness (Second Degree) Burn	2	2
Bradycardia	2	2
Death	2	2
Cardiac Perforation	2	2
Angina	2	2
Thrombosis/Thrombus	2	2
Transient Ischemic Attack	2	2
Atrial Fibrillation	2	2
Perforation	2	2
Hepatitis	1	1
Arrhythmia	1	1
Hypersensitivity/Allergic reaction	1	1
Paralysis	1	1
Electrolyte Imbalance	1	1
Overdose	1	1
Thrombosis	1	1
Chest Pain	1	1
Non specific EKG/ECG Changes	1	1
Exposure to Body Fluids	1	1
Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edwards Lifesciences, LLC	II	Jun-25-2021