Catheter, Embolectomy

Device Code: 813

Product Code(s): DXE

Device Classification Information

• Device Type ID: 813
• Device Name: Catheter, Embolectomy
• Regulation Description: Embolectomy Catheter.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Interventional Cardiology Devices Branch (ICDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.5150 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DXE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 813
• Device: Catheter, Embolectomy
• Product Code: DXE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Embolectomy Catheter.
• CFR Regulation Number: 870.5150 [🔎]

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CAPTURE VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	2
INARI MEDICAL
	SUBSTANTIALLY EQUIVALENT	11
MEDRAD INTERVENTIONAL/POSSIS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	7
POSSIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
WALK VASCULAR, LLC
	SE - WITH LIMITATIONS	2
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Catheter	704
Aspiration Issue	480
Device Displays Incorrect Message	433
Break	328
Kinked	222
Material Deformation	171
Adverse Event Without Identified Device Or Use Problem	169
Device Damaged Prior To Use	143
Physical Resistance	122
Material Separation	111
Shaft	86
Out-Of-Box Failure	75
Material Rupture	73
Device Handling Problem	69
Entrapment Of Device	67
Detachment Of Device Component	66
Device Operates Differently Than Expected	58
Failure To Advance	58
Failure To Prime	52
Deflation Problem	52
Fracture	50
Collapse	48
Leak / Splash	41
Detachment Of Device Or Device Component	35
Physical Resistance / Sticking	34
Burst Container Or Vessel	34
Bent	31
Fluid Leak	31
Deformation Due To Compressive Stress	29
Tip	29
Stretched	26
Hole In Material	26
Suction Problem	21
Difficult To Remove	21
Difficult To Advance	20
Unraveled Material	17
Difficult To Insert	15
Pump	14
Material Twisted / Bent	14
Material Integrity Problem	13
Material Fragmentation	13
Crack	12
Material Puncture / Hole	12
Material Perforation	10
Torn Material	10
Mechanical Jam	9
Device Dislodged Or Dislocated	9
Retraction Problem	8
Stent	8
Generator	7
Device Slipped	7
Display Or Visual Feedback Problem	6
Decrease In Suction	6
Complete Blockage	6
Device Damaged By Another Device	6
Device Packaging Compromised	6
Device Difficult To Setup Or Prepare	6
Use Of Device Problem	6
Material Frayed	5
Contamination During Use	5
Device Operational Issue	5
No Pressure	5
Hub	5
Cut In Material	5
Defective Device	5
Mechanical Problem	4
Appropriate Term/Code Not Available	4
Material Split, Cut Or Torn	4
Device Fell	3
Improper Flow Or Infusion	3
Device Contamination With Chemical Or Other Material	3
Inadequacy Of Device Shape And/or Size	3
Folded	3
Component Or Accessory Incompatibility	2
Unsealed Device Packaging	2
Off-Label Use	2
Sticking	2
Device-Device Incompatibility	2
Insufficient Information	2
Overheating Of Device	2
Device Or Device Fragments Location Unknown	2
Split	2
Device Markings / Labelling Problem	2
Tear, Rip Or Hole In Device Packaging	2
Misconnection	2
Device Inoperable	2
Improper Or Incorrect Procedure Or Method	2
Compatibility Problem	2
Device Contamination With Body Fluid	2
Inflation Problem	2
Difficult To Open Or Close	2
Component Missing	2
Structural Problem	2
Failure To Pump	2
Seal	2
Shipping Damage Or Problem	2
Occlusion Within Device	2
Connection Problem	2
Hemo Valve	1
Wire	1
Total Device Problems	4349

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	Sep-30-2016
2	Boston Scientific Corporation	I	Apr-18-2016
3	Boston Scientific Corporation	II	Aug-13-2015
4	Edwards Lifesciences, LLC	II	Aug-26-2017
5	LeMaitre Vascular, Inc.	II	Dec-04-2015

TPLC Last Update: 2019-04-02 19:42:18