TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Pacing Problem	126	126
Incorrect Measurement	101	101
Material Rupture	97	97
Incorrect, Inadequate or Imprecise Result or Readings	67	68
Inflation Problem	53	53
Fluid/Blood Leak	52	52
Deflation Problem	50	50
Leak/Splash	50	50
Burst Container or Vessel	46	46
Detachment of Device or Device Component	44	44
Adverse Event Without Identified Device or Use Problem	43	43
Failure to Deflate	36	37
Material Fragmentation	28	28
Material Split, Cut or Torn	27	28
Difficult to Advance	24	24
Obstruction of Flow	23	23
No Pacing	22	22
Break	21	21
Difficult to Remove	15	15
Material Separation	14	14
Material Deformation	11	11
Crack	10	10
Failure to Capture	10	10
Physical Resistance/Sticking	9	9
Air/Gas in Device	9	9
Inaccurate Information	8	8
Difficult or Delayed Positioning	8	8
No Device Output	8	8
Material Puncture/Hole	8	8
Defective Device	7	7
Appropriate Term/Code Not Available	7	7
Gas/Air Leak	6	6
Unable to Obtain Readings	6	6
Contamination	6	6
High Readings	5	5
Material Integrity Problem	5	5
Material Twisted/Bent	4	4
Difficult to Insert	4	4
Insufficient Information	4	4
Therapeutic or Diagnostic Output Failure	3	4
Separation Problem	3	3
Unintended Deflation	3	3
Difficult to Flush	3	3
Malposition of Device	3	3
Capturing Problem	3	3
Failure to Advance	3	3
Component Missing	3	4
Tear, Rip or Hole in Device Packaging	3	3
Use of Device Problem	2	2
Material Perforation	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	912	915
Insufficient Information	78	78
Hemorrhage/Bleeding	23	24
Cardiac Tamponade	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Low Blood Pressure/ Hypotension	7	7
Great Vessel Perforation	7	7
Hemoptysis	7	7
Cardiac Perforation	6	6
Cardiac Arrest	6	6
Needle Stick/Puncture	4	4
Low Oxygen Saturation	3	3
Perforation of Vessels	3	3
Tachycardia	3	3
Bradycardia	3	3
Dyspnea	3	3
Perforation	3	3
Vascular Dissection	3	3
Failure of Implant	3	3
Arrhythmia	3	3
Foreign Body In Patient	2	2
Thrombosis/Thrombus	2	2
Pain	2	2
No Information	2	2
Anaphylactic Shock	2	2
Extravasation	2	2
Cough	2	2
Swelling/ Edema	2	2
Respiratory Arrest	2	2
Pseudoaneurysm	2	2
Bacterial Infection	2	2
Unspecified Vascular Problem	2	2
Rupture	1	1
Atrial Fibrillation	1	1
Embolism/Embolus	1	1
Chest Pain	1	1
Discomfort	1	1
Tricuspid Valve Insufficiency/ Regurgitation	1	1
Physical Entrapment	1	1
Bronchial Hemorrhage	1	1
Ectopic Heartbeat	1	1
No Consequences Or Impact To Patient	1	1
Heart Block	1	1
Hypersensitivity/Allergic reaction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Becton, Dickinson and Company	II	May-15-2026
2	Edwards Lifesciences, LLC	II	Apr-12-2023
3	LeMaitre Vascular, Inc.	II	May-12-2025