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	140	141
Incorrect, Inadequate or Imprecise Result or Readings	135	135
Material Separation	88	88
Incorrect Measurement	68	68
Communication or Transmission Problem	61	61
Break	60	60
Adverse Event Without Identified Device or Use Problem	54	54
Contamination	53	53
Difficult to Remove	52	52
Failure to Advance	37	37
Deformation Due to Compressive Stress	35	35
Difficult to Advance	28	28
Fluid/Blood Leak	27	27
Fracture	24	24
Improper or Incorrect Procedure or Method	23	23
Leak/Splash	15	15
Use of Device Problem	15	15
Material Split, Cut or Torn	13	13
Peeled/Delaminated	13	13
Air/Gas in Device	12	12
Inaccurate Flow Rate	11	11
Stretched	10	10
Disconnection	10	10
Insufficient Information	9	9
Mechanical Problem	8	8
Obstruction of Flow	8	8
Device Contaminated During Manufacture or Shipping	8	8
Physical Resistance/Sticking	7	7
Entrapment of Device	7	7
Loose or Intermittent Connection	7	7
Material Twisted/Bent	7	7
Output Problem	6	6
Material Deformation	6	6
Pacing Problem	5	5
Delivered as Unsterile Product	5	5
Failure to Zero	5	5
Material Frayed	5	5
Material Integrity Problem	5	5
Unsealed Device Packaging	4	4
Nonstandard Device	4	4
Device Contamination with Chemical or Other Material	4	4
Appropriate Term/Code Not Available	4	4
Contamination /Decontamination Problem	3	3
Calibration Problem	3	3
Inaccurate Information	3	3
Tear, Rip or Hole in Device Packaging	3	3
High Readings	2	2
Material Discolored	2	2
Crack	2	2
No Device Output	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	669	670
Hemorrhage/Bleeding	35	35
Vascular Dissection	25	25
Insufficient Information	24	24
Foreign Body In Patient	16	16
Cerebrospinal Fluid Leakage	14	14
Device Embedded In Tissue or Plaque	13	13
Air Embolism	11	11
Pericardial Effusion	10	10
No Consequences Or Impact To Patient	9	9
Embolism/Embolus	8	8
Low Blood Pressure/ Hypotension	7	7
Loss of consciousness	7	7
Burn(s)	6	6
Myocardial Infarction	4	4
Obstruction/Occlusion	4	4
No Known Impact Or Consequence To Patient	4	4
Cardiac Arrest	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Vasoconstriction	3	3
Perforation of Vessels	3	3
Ventricular Fibrillation	3	3
Cardiac Tamponade	3	3
Full thickness (Third Degree) Burn	2	2
Ischemia Stroke	2	2
Partial thickness (Second Degree) Burn	2	2
Bradycardia	2	2
Cardiac Perforation	2	2
Angina	2	2
Thrombosis/Thrombus	2	2
Transient Ischemic Attack	2	2
Atrial Fibrillation	2	2
High Blood Pressure/ Hypertension	2	2
Electrolyte Imbalance	1	1
Paralysis	1	1
Cognitive Changes	1	1
Ischemia	1	1
No Patient Involvement	1	1
Exposure to Body Fluids	1	1
Pain	1	1
Tics/Tremor	1	1
Fluid Discharge	1	1
Perforation	1	1
Renal Failure	1	1
Muscle Weakness	1	1
Aneurysm	1	1
Hematoma	1	1
Dizziness	1	1
Memory Loss/Impairment	1	1
Hypersensitivity/Allergic reaction	1	1

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