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	433	1165
Fracture	138	138
Detachment of Device or Device Component	107	107
Material Separation	98	98
Physical Resistance/Sticking	97	219
Device-Device Incompatibility	84	84
Difficult to Remove	75	75
Defective Device	74	74
Positioning Problem	73	73
Difficult to Advance	61	61
Break	57	179
Material Deformation	53	53
Entrapment of Device	32	32
Material Perforation	25	25
Material Integrity Problem	25	25
Device Contamination with Chemical or Other Material	16	16
Display or Visual Feedback Problem	12	12
Unraveled Material	11	11
Material Frayed	11	11
Manufacturing, Packaging or Shipping Problem	10	10
Material Split, Cut or Torn	9	9
Component or Accessory Incompatibility	9	9
Sharp Edges	8	8
Loss of or Failure to Bond	7	7
Use of Device Problem	7	7
Mechanical Jam	7	373
Material Twisted/Bent	7	7
Insufficient Information	6	6
Mechanical Problem	6	6
Device Damaged by Another Device	6	6
Deformation Due to Compressive Stress	6	6
Failure to Advance	6	6
Fluid/Blood Leak	6	6
Device Dislodged or Dislocated	5	5
Failure to Cut	5	127
Material Fragmentation	5	5
Difficult to Insert	4	4
Leak/Splash	4	4
Unsealed Device Packaging	4	4
Tear, Rip or Hole in Device Packaging	4	4
Device Contaminated During Manufacture or Shipping	4	4
Migration	4	4
Crack	4	4
Difficult to Open or Remove Packaging Material	3	3
Component Missing	3	3
Retraction Problem	3	3
Partial Blockage	3	3
Mechanics Altered	3	125
Unintended Movement	3	3
Complete Blockage	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	420	1030
Pericardial Effusion	185	429
Foreign Body In Patient	132	254
Low Blood Pressure/ Hypotension	120	120
Great Vessel Perforation	103	347
Perforation of Vessels	86	696
Cardiac Perforation	80	80
Cardiac Tamponade	76	76
Thrombosis/Thrombus	73	73
Hemorrhage/Bleeding	37	37
Device Embedded In Tissue or Plaque	33	33
No Consequences Or Impact To Patient	29	29
Iatrogenic Source	26	148
Insufficient Information	24	24
Air Embolism	22	22
No Known Impact Or Consequence To Patient	22	22
Cardiac Arrest	21	21
Hematoma	20	20
Perforation	20	20
Non specific EKG/ECG Changes	17	17
Vascular Dissection	14	14
Death	13	135
Arrhythmia	12	12
Laceration(s)	11	11
Asystole	8	8
Heart Block	8	8
Bradycardia	8	8
Pain	7	7
Atrial Perforation	7	7
Retroperitoneal Hemorrhage	7	7
Pleural Effusion	6	6
Tachycardia	5	5
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Pneumothorax	4	4
Myocardial Infarction	4	4
Ischemia	4	4
Pseudoaneurysm	3	3
Diminished Pulse Pressure	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Patient Involvement	3	3
Hypoxia	3	3
Thromboembolism	3	3
Stroke/CVA	3	3
Pulmonary Embolism	3	3
Rupture	3	3
Ventricular Fibrillation	3	3
Vasoconstriction	3	3
Respiratory Arrest	2	2
Calcium Deposits/Calcification	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	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