TPLC - Total Product Life Cycle

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Device	dilator, vessel, for percutaneous catheterization
Regulation Description	Vessel dilator 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	485	1217
Fracture	144	144
Detachment of Device or Device Component	117	117
Material Separation	101	101
Physical Resistance/Sticking	100	222
Positioning Problem	100	100
Device-Device Incompatibility	89	89
Defective Device	81	81
Difficult to Remove	79	79
Difficult to Advance	72	72
Break	65	187
Material Deformation	55	55
Entrapment of Device	35	35
Material Perforation	31	31
Material Integrity Problem	25	25
Display or Visual Feedback Problem	17	17
Device Contamination with Chemical or Other Material	17	17
Mechanical Problem	13	13
Unraveled Material	12	12
Material Frayed	11	11
Material Split, Cut or Torn	10	10
Manufacturing, Packaging or Shipping Problem	10	10
Component or Accessory Incompatibility	9	9
Sharp Edges	8	8
Loss of or Failure to Bond	7	7
Mechanical Jam	7	373
Insufficient Information	7	7
Material Twisted/Bent	7	7
Use of Device Problem	7	7
Fluid/Blood Leak	6	6
Deformation Due to Compressive Stress	6	6
Device Dislodged or Dislocated	6	6
Failure to Advance	6	6
Device Damaged by Another Device	6	6
Material Fragmentation	6	6
Device Contaminated During Manufacture or Shipping	5	5
Migration	5	5
Crack	5	5
Failure to Cut	5	127
Leak/Splash	4	4
Difficult to Insert	4	4
Stretched	4	4
Tear, Rip or Hole in Device Packaging	4	4
Retraction Problem	4	4
Unsealed Device Packaging	4	4
Separation Problem	3	3
Difficult to Open or Remove Packaging Material	3	3
Inadequacy of Device Shape and/or Size	3	3
Partial Blockage	3	3
Complete Blockage	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	462	1072
Pericardial Effusion	233	477
Low Blood Pressure/ Hypotension	156	156
Foreign Body In Patient	140	262
Great Vessel Perforation	116	360
Cardiac Perforation	100	100
Cardiac Tamponade	96	96
Perforation of Vessels	93	703
Thrombosis/Thrombus	77	77
Hemorrhage/Bleeding	44	44
Device Embedded In Tissue or Plaque	36	36
No Consequences Or Impact To Patient	29	29
Iatrogenic Source	26	148
Cardiac Arrest	26	26
Air Embolism	25	25
Insufficient Information	25	25
Hematoma	25	25
Perforation	22	22
No Known Impact Or Consequence To Patient	22	22
Non specific EKG/ECG Changes	20	20
Vascular Dissection	16	16
Arrhythmia	13	13
Death	13	135
Laceration(s)	11	11
Heart Block	9	9
Bradycardia	9	9
Atrial Perforation	7	7
Tachycardia	7	7
Asystole	7	7
Pain	7	7
Pleural Effusion	7	7
Retroperitoneal Hemorrhage	7	7
Unspecified Infection	6	6
Unspecified Tissue Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Ischemia	5	5
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Pulmonary Embolism	4	4
Hemothorax	4	4
Stroke/CVA	4	4
Pneumothorax	4	4
Myocardial Infarction	4	4
Rupture	3	3
Fistula	3	3
Diminished Pulse Pressure	3	3
Thromboembolism	3	3
Ventricular Fibrillation	3	3
Vasoconstriction	3	3
Pseudoaneurysm	3	3
Hypoxia	3	3

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	Galt Medical Corporation	II	May-07-2025
6	Maquet Cardiovascular Us Sales, Llc	II	Mar-27-2020
7	Merit Medical Systems, Inc.	II	Sep-20-2024