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
EDWARDS LIFECIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
OPSENS, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZURICH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	206	207
Incorrect, Inadequate or Imprecise Result or Readings	184	184
Communication or Transmission Problem	109	109
Material Separation	93	93
Incorrect Measurement	76	76
Break	65	65
Adverse Event Without Identified Device or Use Problem	63	63
Contamination	59	59
Difficult to Remove	52	52
Failure to Advance	50	50
Device Contamination with Chemical or Other Material	38	38
Fracture	35	35
Fluid/Blood Leak	34	34
Deformation Due to Compressive Stress	31	31
Difficult to Advance	31	31
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
Material Integrity Problem	16	16
Use of Device Problem	16	16
Peeled/Delaminated	13	13
Entrapment of Device	13	13
Material Split, Cut or Torn	13	13
Output Problem	12	12
Physical Resistance/Sticking	11	11
Air/Gas in Device	11	11
Inaccurate Flow Rate	11	11
Stretched	10	10
Insufficient Information	9	9
Loose or Intermittent Connection	9	9
Obstruction of Flow	9	9
Mechanical Problem	8	8
Device Contaminated During Manufacture or Shipping	8	8
Defective Device	7	7
Material Twisted/Bent	7	7
Unsealed Device Packaging	6	6
Calibration Problem	6	6
Mechanical Jam	5	5
Pacing Problem	5	5
Material Frayed	5	5
Appropriate Term/Code Not Available	5	5
Delivered as Unsterile Product	5	5
Positioning Problem	4	4
Failure to Clean Adequately	4	4
Device Damaged Prior to Use	3	3
Tear, Rip or Hole in Device Packaging	3	3
Crack	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	656	657
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	16	16
Cerebrospinal Fluid Leakage	14	14
Air Embolism	12	12
Pericardial Effusion	10	10
No Code Available	9	9
Low Blood Pressure/ Hypotension	8	8
Embolism/Embolus	8	8
Burn(s)	8	8
Blood Loss	8	8
Loss of consciousness	7	7
Unspecified Infection	4	4
Myocardial Infarction	4	4
Obstruction/Occlusion	4	4
Perforation of Vessels	3	3
Ventricular Fibrillation	3	3
Cardiac Arrest	3	3
High Blood Pressure/ Hypertension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Vasoconstriction	3	3
Ischemia Stroke	2	2
Full thickness (Third Degree) Burn	2	2
Partial thickness (Second Degree) Burn	2	2
Death	2	2
Bradycardia	2	2
Thrombosis/Thrombus	2	2
Perforation	2	2
Angina	2	2
Cardiac Tamponade	2	2
Transient Ischemic Attack	2	2
Atrial Fibrillation	2	2
Hematoma	1	1
Electrolyte Imbalance	1	1
Overdose	1	1
Ischemia	1	1
Hepatitis	1	1
Paralysis	1	1
Cardiac Perforation	1	1
Dizziness	1	1
Memory Loss/Impairment	1	1
Exposure to Body Fluids	1	1
Chest Pain	1	1
Thrombosis	1	1

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