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

Premarket Reviews
Manufacturer	Decision
BAYLIS MEDICAL COMPANY INC.
	SUBSTANTIALLY EQUIVALENT	4
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
MEDRON, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRANETICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K212784 TightRail Guardian Motorized Dilator Sheath
TOGO MEDIKIT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
XCARDIA INNOVATION LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	445	1177
Fracture	138	138
Detachment of Device or Device Component	109	109
Material Separation	98	98
Physical Resistance/Sticking	97	219
Device-Device Incompatibility	85	85
Positioning Problem	82	82
Difficult to Remove	76	76
Defective Device	74	74
Difficult to Advance	67	67
Break	58	180
Material Deformation	53	53
Entrapment of Device	33	33
Material Perforation	28	28
Material Integrity Problem	25	25
Device Contamination with Chemical or Other Material	16	16
Display or Visual Feedback Problem	12	12
Unraveled Material	12	12
Material Frayed	11	11
Manufacturing, Packaging or Shipping Problem	10	10
Component or Accessory Incompatibility	9	9
Material Split, Cut or Torn	9	9
Mechanical Problem	9	9
Sharp Edges	8	8
Loss of or Failure to Bond	7	7
Mechanical Jam	7	373
Material Twisted/Bent	7	7
Use of Device Problem	7	7
Fluid/Blood Leak	6	6
Deformation Due to Compressive Stress	6	6
Failure to Advance	6	6
Device Damaged by Another Device	6	6
Insufficient Information	6	6
Material Fragmentation	5	5
Device Dislodged or Dislocated	5	5
Failure to Cut	5	127
Leak/Splash	4	4
Device Contaminated During Manufacture or Shipping	4	4
Difficult to Insert	4	4
Unsealed Device Packaging	4	4
Migration	4	4
Tear, Rip or Hole in Device Packaging	4	4
Crack	4	4
Separation Problem	3	3
Stretched	3	3
Component Missing	3	3
Difficult to Open or Remove Packaging Material	3	3
Unintended Movement	3	3
Inadequacy of Device Shape and/or Size	3	3
Mechanics Altered	3	125

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	432	1042
Pericardial Effusion	196	440
Foreign Body In Patient	133	255
Low Blood Pressure/ Hypotension	129	129
Great Vessel Perforation	105	349
Perforation of Vessels	86	696
Cardiac Perforation	83	83
Cardiac Tamponade	79	79
Thrombosis/Thrombus	74	74
Hemorrhage/Bleeding	40	40
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
Hematoma	21	21
Perforation	21	21
Cardiac Arrest	21	21
Non specific EKG/ECG Changes	18	18
Vascular Dissection	15	15
Death	13	135
Arrhythmia	13	13
Laceration(s)	11	11
Bradycardia	8	8
Asystole	8	8
Heart Block	8	8
Pain	7	7
Atrial Perforation	7	7
Retroperitoneal Hemorrhage	7	7
Tachycardia	6	6
Pleural Effusion	6	6
Tricuspid Valve Insufficiency/ Regurgitation	5	5
Myocardial Infarction	4	4
Ischemia	4	4
Pneumothorax	4	4
Stroke/CVA	4	4
Rupture	3	3
Pseudoaneurysm	3	3
Hypoxia	3	3
Unspecified Tissue Injury	3	3
Diminished Pulse Pressure	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Vasoconstriction	3	3
Fistula	3	3
Ventricular Fibrillation	3	3
Thromboembolism	3	3
No Patient Involvement	3	3
Pulmonary Embolism	3	3
Swelling/ Edema	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