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	159	160
Incorrect, Inadequate or Imprecise Result or Readings	145	145
Material Separation	100	100
Incorrect Measurement	75	75
Communication or Transmission Problem	72	72
Difficult to Remove	70	70
Break	69	69
Contamination	63	63
Adverse Event Without Identified Device or Use Problem	54	54
Deformation Due to Compressive Stress	41	41
Failure to Advance	41	41
Difficult to Advance	32	32
Improper or Incorrect Procedure or Method	28	28
Fluid/Blood Leak	23	23
Fracture	23	23
Material Split, Cut or Torn	18	18
Obstruction of Flow	17	17
Air/Gas in Device	17	17
Peeled/Delaminated	15	15
Use of Device Problem	15	15
Stretched	14	14
Inaccurate Flow Rate	12	12
Leak/Splash	11	11
Nonstandard Device	10	10
Entrapment of Device	10	10
Insufficient Device Problem Information	10	10
Disconnection	9	9
Mechanical Problem	8	8
Device Contaminated During Manufacture or Shipping	8	8
Low Readings	7	7
Loose or Intermittent Connection	6	6
Material Twisted/Bent	6	6
Material Frayed	6	6
Delivered as Unsterile Product	6	6
Material Deformation	6	6
Failure to Zero	5	5
Material Integrity Problem	5	5
Pacing Problem	5	5
Output Problem	5	5
Appropriate Device Problem Term/Code Not Available	5	5
Device Contamination with Chemical or Other Material	5	5
Difficult or Delayed Positioning	5	5
Unsealed Device Packaging	4	4
Inaccurate Delivery	4	4
Calibration Problem	4	4
Inaccurate Information	3	3
Tear, Rip or Hole in Device Packaging	3	3
Solder Joint Fracture	3	3
Contamination /Decontamination Problem	3	3
Physical Resistance/Sticking	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	774	775
Hemorrhage/Blood Loss/Bleeding	42	42
Vascular Dissection	25	25
Insufficient Information	24	24
Device Embedded In Tissue or Plaque	17	17
Foreign Body In Patient	17	17
Cerebrospinal Fluid Leakage	14	14
Air Embolism	12	12
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)	7	7
High Blood Pressure/ Hypertension	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Myocardial Infarction	4	4
Obstruction/Occlusion	4	4
Cardiac Arrest	4	4
No Known Impact Or Consequence To Patient	4	4
Vasoconstriction	3	3
Perforation of Vessels	3	3
Cardiac Tamponade	3	3
Ventricular Fibrillation	3	3
Cardiac Perforation	3	3
Hypervolemia	2	2
Ischemia Stroke	2	2
Full thickness (Third Degree) Burn	2	2
Unspecified Respiratory Problem	2	2
Partial thickness (Second Degree) Burn	2	2
Fluid Discharge	2	2
Bradycardia	2	2
Thrombosis/Thrombus	2	2
Angina	2	2
Transient Ischemic Attack	2	2
Atrial Fibrillation	2	2
Weight Changes	2	2
Electrolyte Imbalance	1	1
Paralysis	1	1
Exposure to Body Fluids	1	1
No Patient Involvement	1	1
Cognitive Changes	1	1
Pain	1	1
Tics/Tremor	1	1
Perforation	1	1
Renal Failure	1	1
Unspecified Tissue Injury	1	1
Ischemia	1	1
Hematoma	1	1
Dizziness	1	1

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