Device, Hemostasis, Vascular

Device Code: 1027

Product Code(s): MGB

Device Classification Information

• Device Type ID: 1027
• Device Name: Device, Hemostasis, Vascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Structural Heart Devices Branch (SHDB)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: MGB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1027
• Device: Device, Hemostasis, Vascular
• Product Code: MGB
• FDA Device Classification: Class 3 Medical Device

Device Problems
Failure To Cycle	987
Device Operates Differently Than Expected	769
Positioning Failure	608
Adverse Event Without Identified Device Or Use Problem	564
Material Separation	520
Detachment Of Device Or Device Component	449
Activation, Positioning Or Separation Problem	319
Improper Or Incorrect Procedure Or Method	279
Detachment Of Device Component	251
Difficult To Insert	249
Malposition Of Device	232
Difficult To Remove	206
Material Rupture	198
Insufficient Information	175
Difficult Or Delayed Positioning	154
Plug	141
Patient Device Interaction Problem	141
Retraction Problem	137
Balloon	129
Kinked	119
Failure To Advance	112
Component Missing	111
Mechanical Jam	103
Break	93
Activation Failure Including Expansion Failures	87
Material Deformation	86
Entrapment Of Device	83
Difficult To Open Or Close	81
Separation Failure	62
Obstruction Of Flow	60
Migration Or Expulsion Of Device	60
Therapy Delivered To Incorrect Body Area	59
Difficult To Advance	56
Decrease In Pressure	48
Bent	47
Unintended Movement	46
Catheter	41
Suture	39
Product Quality Problem	39
Off-Label Use	39
Physical Resistance / Sticking	38
Partial Blockage	34
Difficult Or Delayed Activation	33
Deflation Problem	33
Tube	32
Deformation Due To Compressive Stress	30
Fracture	30
Physical Resistance	28
Burst Container Or Vessel	25
Defective Component	23
Failure To Fire	22
Material Split, Cut Or Torn	22
Failure To Cut	22
Inadequate Or Insufficient Training	20
Appropriate Term/Code Not Available	19
Device Operational Issue	19
Difficult To Position	17
Mechanism	16
Device Dislodged Or Dislocated	15
Device Issue	15
Firing Problem	13
Component Misassembled	13
Device Deployer	13
Material Twisted / Bent	12
No Apparent Adverse Event	12
Material Puncture / Hole	11
Split	11
Expulsion	11
Leak / Splash	11
Device Damaged Prior To Use	10
Device Damaged By Another Device	9
Wire	9
Connection Problem	7
Device Contamination With Chemical Or Other Material	7
Sticking	6
Crack	6
Noise, Audible	6
Activation Problem	6
Use Of Device Problem	5
Device Component Or Accessory	5
Premature Activation	5
Stretched	4
Loose Or Intermittent Connection	4
Positioning Problem	4
Switch, Push Button	4
Pressure Problem	4
Unsealed Device Packaging	4
Material Integrity Problem	4
Migration	4
Device Difficult To Setup Or Prepare	4
Seal	4
Physical Property Issue	4
Material Fragmentation	3
Accessory Incompatible	3
Indicator	3
Device Expiration Issue	3
Gears	3
Mechanical Problem	3
Device Slipped	2
Carrier	2
Total Device Problems	8726

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Vascular	II	Feb-15-2017
2	AccessClosure, Inc., A Cardinal Health Company	II	Aug-03-2016
3	EXP Pharmaceutical Services Corp	II	Jul-24-2015
4	Terumo Medical Corp	II	Jun-29-2018

TPLC Last Update: 2019-04-02 19:46:54