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	156	157
Incorrect, Inadequate or Imprecise Result or Readings	142	142
Material Separation	97	97
Incorrect Measurement	70	70
Break	67	67
Communication or Transmission Problem	65	65
Difficult to Remove	61	61
Contamination	58	58
Adverse Event Without Identified Device or Use Problem	54	54
Failure to Advance	39	39
Deformation Due to Compressive Stress	36	36
Difficult to Advance	30	30
Fluid/Blood Leak	29	29
Improper or Incorrect Procedure or Method	25	25
Fracture	24	24
Air/Gas in Device	18	18
Material Split, Cut or Torn	17	17
Leak/Splash	16	16
Use of Device Problem	15	15
Stretched	13	13
Obstruction of Flow	13	13
Peeled/Delaminated	13	13
Inaccurate Flow Rate	12	12
Disconnection	10	10
Insufficient Information	10	10
Device Contaminated During Manufacture or Shipping	8	8
Mechanical Problem	8	8
Material Twisted/Bent	7	7
Physical Resistance/Sticking	7	7
Loose or Intermittent Connection	7	7
Entrapment of Device	7	7
Material Deformation	6	6
Nonstandard Device	6	6
Output Problem	6	6
Material Frayed	5	5
Failure to Zero	5	5
Material Integrity Problem	5	5
Pacing Problem	5	5
Appropriate Term/Code Not Available	5	5
Low Readings	5	5
Delivered as Unsterile Product	5	5
Unsealed Device Packaging	4	4
Calibration Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Inaccurate Delivery	4	4
Tear, Rip or Hole in Device Packaging	3	3
Inaccurate Information	3	3
Contamination /Decontamination Problem	3	3
Solder Joint Fracture	3	3
Device Damaged Prior to Use	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	718	719
Hemorrhage/Bleeding	40	40
Vascular Dissection	25	25
Insufficient Information	24	24
Device Embedded In Tissue or Plaque	17	17
Foreign Body In Patient	16	16
Cerebrospinal Fluid Leakage	14	14
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
High Blood Pressure/ Hypertension	4	4
Obstruction/Occlusion	4	4
Myocardial Infarction	4	4
Cardiac Arrest	4	4
No Known Impact Or Consequence To Patient	4	4
Vasoconstriction	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Perforation of Vessels	3	3
Cardiac Tamponade	3	3
Ventricular Fibrillation	3	3
Hypervolemia	2	2
Ischemia Stroke	2	2
Full thickness (Third Degree) Burn	2	2
Weight Changes	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
Cardiac Perforation	2	2
Angina	2	2
Transient Ischemic Attack	2	2
Atrial Fibrillation	2	2
Non specific EKG/ECG Changes	1	1
Paralysis	1	1
Cyanosis	1	1
Exposure to Body Fluids	1	1
No Patient Involvement	1	1
Pain	1	1
Electrolyte Imbalance	1	1
Renal Failure	1	1
Cognitive Changes	1	1
Superficial (First Degree) Burn	1	1
Tics/Tremor	1	1
Aneurysm	1	1
Perforation	1	1

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