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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	182	183
Incorrect, Inadequate or Imprecise Result or Readings	159	159
Material Separation	99	99
Communication or Transmission Problem	95	95
Incorrect Measurement	77	77
Difficult to Remove	68	68
Break	63	63
Contamination	62	62
Adverse Event Without Identified Device or Use Problem	62	62
Failure to Advance	44	44
Deformation Due to Compressive Stress	38	38
Difficult to Advance	36	36
Fracture	31	31
Improper or Incorrect Procedure or Method	29	29
Fluid/Blood Leak	24	24
Device Contamination with Chemical or Other Material	23	23
Material Split, Cut or Torn	18	18
Air/Gas in Device	17	17
Obstruction of Flow	16	16
Peeled/Delaminated	15	15
Use of Device Problem	15	15
Stretched	13	13
Leak/Splash	13	13
Material Integrity Problem	13	13
Material Deformation	13	13
Inaccurate Flow Rate	12	12
Entrapment of Device	11	11
Failure to Zero	11	11
Insufficient Device Problem Information	10	10
Disconnection	9	9
Device Contaminated During Manufacture or Shipping	8	8
Nonstandard Device	8	8
Mechanical Problem	8	8
Unsealed Device Packaging	7	7
Calibration Problem	7	7
Output Problem	7	7
Low Readings	7	7
Material Twisted/Bent	6	6
Material Frayed	6	6
Pacing Problem	5	5
Delivered as Unsterile Product	5	5
Loose or Intermittent Connection	5	5
Appropriate Device Problem Term/Code Not Available	5	5
Inaccurate Delivery	4	4
Contamination /Decontamination Problem	3	3
Inaccurate Information	3	3
Physical Resistance/Sticking	3	3
Tear, Rip or Hole in Device Packaging	3	3
Solder Joint Fracture	3	3
Material Discolored	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	758	759
No Consequences Or Impact To Patient	101	101
No Known Impact Or Consequence To Patient	67	67
Hemorrhage/Blood Loss/Bleeding	43	43
Vascular Dissection	26	26
Insufficient Information	26	26
Device Embedded In Tissue or Plaque	19	19
Foreign Body In Patient	17	17
Cerebrospinal Fluid Leakage	14	14
Air Embolism	13	13
Pericardial Effusion	10	10
No Patient Involvement	9	9
Low Blood Pressure/ Hypotension	8	8
Embolism/Embolus	8	8
Blood Loss	7	7
Burn(s)	7	7
Loss of consciousness	7	7
High Blood Pressure/ Hypertension	5	5
No Code Available	4	4
Myocardial Infarction	4	4
Cardiac Arrest	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Obstruction/Occlusion	4	4
Perforation of Vessels	3	3
Vasoconstriction	3	3
Cardiac Perforation	3	3
Ventricular Fibrillation	3	3
Cardiac Tamponade	3	3
Thrombosis/Thrombus	2	2
Transient Ischemic Attack	2	2
Unspecified Respiratory Problem	2	2
Atrial Fibrillation	2	2
Bradycardia	2	2
Weight Changes	2	2
Hypervolemia	2	2
Perforation	2	2
Full thickness (Third Degree) Burn	2	2
Fluid Discharge	2	2
Ischemia Stroke	2	2
Partial thickness (Second Degree) Burn	2	2
Angina	2	2
Low Oxygen Saturation	1	1
Cyanosis	1	1
Dizziness	1	1
Superficial (First Degree) Burn	1	1
Renal Failure	1	1
Death	1	1
Decreased Level of Consciousness	1	1
Exposure to Body Fluids	1	1
Hematoma	1	1

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