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
Incorrect, Inadequate or Imprecise Result or Readings	148	148
Detachment of Device or Device Component	138	138
Material Separation	80	80
Communication or Transmission Problem	77	77
Incorrect Measurement	56	56
Contamination	48	48
Break	45	45
Difficult to Remove	45	45
Adverse Event Without Identified Device or Use Problem	44	44
Failure to Advance	38	38
Fluid/Blood Leak	27	27
Fracture	27	27
Difficult to Advance	23	23
Device Contamination with Chemical or Other Material	22	22
Deformation Due to Compressive Stress	21	21
Improper or Incorrect Procedure or Method	20	20
Leak/Splash	16	16
Material Deformation	13	13
Use of Device Problem	12	12
Material Integrity Problem	12	12
Failure to Zero	12	12
Material Split, Cut or Torn	11	11
Contamination /Decontamination Problem	11	11
Inaccurate Flow Rate	11	11
Output Problem	11	11
Stretched	10	10
Loose or Intermittent Connection	8	8
Disconnection	7	7
Device Contaminated During Manufacture or Shipping	7	7
Peeled/Delaminated	7	7
Mechanical Problem	7	7
Physical Resistance/Sticking	7	7
Material Twisted/Bent	7	7
Unsealed Device Packaging	6	6
Air/Gas in Device	6	6
Entrapment of Device	6	6
Calibration Problem	6	6
Insufficient Information	5	5
Pacing Problem	5	5
Defective Device	4	4
Material Frayed	3	3
Inaccurate Information	3	3
Appropriate Term/Code Not Available	3	3
Crack	3	3
Tear, Rip or Hole in Device Packaging	3	3
Delivered as Unsterile Product	3	3
Flushing Problem	2	2
Device Sensing Problem	2	2
Off-Label Use	2	2
Device Difficult to Setup or Prepare	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	540	540
No Consequences Or Impact To Patient	101	101
No Known Impact Or Consequence To Patient	67	67
Hemorrhage/Bleeding	28	28
Insufficient Information	22	22
Vascular Dissection	22	22
Cerebrospinal Fluid Leakage	13	13
Foreign Body In Patient	13	13
Device Embedded In Tissue or Plaque	11	11
Air Embolism	10	10
No Patient Involvement	9	9
Pericardial Effusion	8	8
Low Blood Pressure/ Hypotension	7	7
Loss of consciousness	7	7
Blood Loss	7	7
Burn(s)	5	5
No Code Available	4	4
High Blood Pressure/ Hypertension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Vasoconstriction	2	2
Atrial Fibrillation	2	2
Obstruction/Occlusion	2	2
Perforation	2	2
Cardiac Arrest	2	2
Transient Ischemic Attack	2	2
Partial thickness (Second Degree) Burn	2	2
Thrombosis/Thrombus	2	2
Bradycardia	2	2
Cyanosis	1	1
Ischemia Stroke	1	1
Full thickness (Third Degree) Burn	1	1
Low Oxygen Saturation	1	1
Ventilator Dependent	1	1
ST Segment Elevation	1	1
Superficial (First Degree) Burn	1	1
Death	1	1
Tissue Damage	1	1
Myocardial Infarction	1	1
Aneurysm	1	1
Perforation of Vessels	1	1
Fluid Discharge	1	1
Pain	1	1
Memory Loss/Impairment	1	1
Dizziness	1	1
Chest Pain	1	1
Exposure to Body Fluids	1	1
Hematoma	1	1
Ventricular Fibrillation	1	1
Paralysis	1	1
Hepatitis	1	1

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