TPLC - Total Product Life Cycle

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Device	dilator, vessel, for percutaneous catheterization
Product Code	DRE
Regulation Number	870.1310
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	399	1131
Fracture	147	147
Material Separation	104	104
Detachment of Device or Device Component	104	104
Physical Resistance/Sticking	97	219
Device-Device Incompatibility	78	78
Difficult to Remove	77	77
Break	62	184
Material Deformation	45	45
Difficult to Advance	44	44
Device Contamination with Chemical or Other Material	43	43
Positioning Problem	42	42
Defective Device	38	38
Entrapment of Device	33	33
Material Integrity Problem	23	23
Manufacturing, Packaging or Shipping Problem	14	14
Mechanical Jam	13	379
Material Frayed	10	10
Component or Accessory Incompatibility	9	9
Unraveled Material	9	9
Material Split, Cut or Torn	8	8
Sharp Edges	8	8
Use of Device Problem	7	7
Loss of or Failure to Bond	7	7
Material Twisted/Bent	7	7
Device Damaged by Another Device	7	7
Material Fragmentation	7	7
Failure to Advance	6	6
Device Dislodged or Dislocated	6	6
Migration	5	5
Failure to Cut	5	127
Insufficient Information	5	5
Display or Visual Feedback Problem	5	5
Deformation Due to Compressive Stress	5	5
Difficult to Insert	4	4
Crack	4	4
Leak/Splash	4	4
Retraction Problem	4	4
Device Contaminated During Manufacture or Shipping	4	4
Tear, Rip or Hole in Device Packaging	4	4
Fluid/Blood Leak	4	4
Unsealed Device Packaging	3	3
Mechanics Altered	3	125
Component Missing	3	3
Difficult to Open or Remove Packaging Material	3	3
Material Disintegration	2	2
Unintended Movement	2	2
Material Perforation	2	2
Stretched	2	2
Device Markings/Labelling Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	312	922
Pericardial Effusion	143	387
Foreign Body In Patient	135	257
Great Vessel Perforation	96	340
Low Blood Pressure/ Hypotension	94	94
Perforation of Vessels	81	691
No Consequences Or Impact To Patient	69	69
Cardiac Perforation	62	62
Cardiac Tamponade	56	56
Thrombosis/Thrombus	52	52
Iatrogenic Source	47	169
Device Embedded In Tissue or Plaque	39	39
No Known Impact Or Consequence To Patient	35	35
Hemorrhage/Bleeding	32	32
Insufficient Information	22	22
Death	21	143
Hematoma	20	20
Perforation	18	18
Embolism	17	17
Cardiac Arrest	12	12
Air Embolism	11	11
Atrial Perforation	10	10
Vascular Dissection	9	9
Laceration(s)	9	9
No Patient Involvement	8	8
Arrhythmia	8	8
Non specific EKG/ECG Changes	7	7
Pleural Effusion	6	6
No Code Available	5	5
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Pain	5	5
Ventricular Fibrillation	4	4
Tachycardia	4	4
Asystole	4	4
Retroperitoneal Hemorrhage	3	3
Vasoconstriction	3	3
Ischemia	3	3
Hypoxia	3	3
Thromboembolism	3	3
Heart Block	3	3
Hemothorax	3	3
Pneumothorax	3	3
Pulmonary Embolism	3	3
High Blood Pressure/ Hypertension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Heart Failure/Congestive Heart Failure	2	2
Calcium Deposits/Calcification	2	2
Pseudoaneurysm	2	2
Vomiting	2	2
Chest Pain	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics, Inc.	II	Mar-21-2024
2	Argon Medical Devices, Inc	II	Aug-14-2020
3	Cardiac Assist, Inc	II	Apr-23-2021
4	Cordis Corporation	II	Jul-15-2021
5	Maquet Cardiovascular Us Sales, Llc	II	Mar-27-2020
6	Merit Medical Systems, Inc.	II	Sep-20-2024