TPLC - Total Product Life Cycle

• Device: device, hemostasis, vascular
• Product Code: MGB
• Device Class: 3

Premarket Approvals (PMA)
2018	2019	2020	2021	2022	2023
23	27	10	17	11	2

MDR Year	MDR Reports	MDR Events
2018	5679	5679
2019	6156	6156
2020	5927	5927
2021	7586	7586
2022	9457	9466

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cycle	13084	13084
Material Separation	3887	3887
Improper or Incorrect Procedure or Method	1977	1977
Malposition of Device	1958	1958
Adverse Event Without Identified Device or Use Problem	1536	1536
Device Operates Differently Than Expected	1196	1196
Patient Device Interaction Problem	1079	1079
Difficult to Remove	973	973
Insufficient Information	971	971
Activation, Positioning or Separation Problem	960	960
Entrapment of Device	951	951
Detachment of Device or Device Component	901	901
Difficult to Insert	890	890
Off-Label Use	860	860
Difficult to Open or Close	757	757
Obstruction of Flow	734	734
Positioning Failure	696	696
Activation Failure	612	612
Material Deformation	599	599
Physical Resistance/Sticking	572	572
Mechanical Jam	534	534
Break	531	531
Detachment Of Device Component	455	455
Failure to Advance	455	455
Decrease in Pressure	434	434
Retraction Problem	374	374
Material Rupture	358	358
Failure to Fire	352	352
Difficult to Advance	300	300
Product Quality Problem	290	290
Deformation Due to Compressive Stress	258	258
Misconnection	221	221
Unintended System Motion	165	165
Material Split, Cut or Torn	157	157
Component Missing	143	143
Appropriate Term/Code Not Available	141	150
Difficult or Delayed Activation	124	124
Premature Activation	118	118
Firing Problem	116	116
Failure to Cut	115	115
Difficult or Delayed Positioning	112	112
Positioning Problem	103	103
Material Twisted/Bent	97	97
Therapy Delivered to Incorrect Body Area	95	95
Inadequate or Insufficient Training	94	94
Activation Problem	94	94
Device Damaged by Another Device	88	88
Unintended Movement	84	84
Migration	83	92
Burst Container or Vessel	80	80
Separation Failure	78	78
Partial Blockage	73	73
Migration or Expulsion of Device	72	72
Noise, Audible	71	71
Use of Device Problem	67	76
Deflation Problem	61	61
Material Puncture/Hole	58	58
Defective Component	57	57
Kinked	53	53
Loosening of Implant Not Related to Bone-Ingrowth	45	45
No Apparent Adverse Event	42	42
Therapeutic or Diagnostic Output Failure	40	40
Component Misassembled	39	39
Material Frayed	37	37
Fracture	35	35
Bent	34	34
Expulsion	33	33
Difficult To Position	32	32
Defective Device	31	31
Leak/Splash	30	30
Crack	29	29
Patient-Device Incompatibility	26	26
Misfire	21	21
Device Dislodged or Dislocated	20	20
Mechanical Problem	20	20
Material Fragmentation	19	19
Accessory Incompatible	19	19
Loose or Intermittent Connection	17	17
Physical Property Issue	15	15
Unsealed Device Packaging	14	14
Stretched	14	14
Separation Problem	13	13
Peeled/Delaminated	11	11
Device Contamination with Chemical or Other Material	11	11
Material Integrity Problem	10	10
Output Problem	9	9
Contamination /Decontamination Problem	8	8
Difficult to Flush	8	8
Failure to Seal	8	8
Image Orientation Incorrect	7	7
Failure to Deliver	7	7
Device Operational Issue	6	6
Pressure Problem	6	6
Torn Material	6	6
Scratched Material	5	5
Device Damaged Prior to Use	5	5
Device Issue	4	4
Physical Resistance	4	4
Failure to Form Staple	4	4
No Flow	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14927	14936
No Consequences Or Impact To Patient	14134	14134
Blood Loss	937	937
Hematoma	848	857
Hemorrhage/Bleeding	709	709
Insufficient Information	481	481
Obstruction/Occlusion	421	421
Tissue Damage	419	419
Pain	366	366
Pseudoaneurysm	326	335
Occlusion	324	324
Unspecified Tissue Injury	320	320
No Known Impact Or Consequence To Patient	309	309
Foreign Body In Patient	301	301
Extravasation	233	233
No Information	215	215
Vascular Dissection	175	175
No Code Available	134	134
Intimal Dissection	132	132
Stenosis	127	127
Unspecified Infection	122	122
Thrombosis	110	110
Thrombosis/Thrombus	106	106
Low Blood Pressure/ Hypotension	98	98
No Patient Involvement	97	97
Ischemia	90	90
Death	81	81
Swelling/ Edema	76	76
Device Embedded In Tissue or Plaque	67	67
Diminished Pulse Pressure	65	65
Perforation	51	51
Perforation of Vessels	47	47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	44	53
Failure of Implant	37	37
Retroperitoneal Hemorrhage	36	36
Inflammation	35	35
Swelling	35	35
Numbness	35	35
Fistula	33	33
Embolism	29	29
Anemia	28	28
Embolism/Embolus	26	26
Aneurysm	22	22
Stroke/CVA	21	21
Renal Failure	20	20
Bruise/Contusion	18	18
Calcium Deposits/Calcification	18	18
Shock	17	17
Sepsis	16	16
Claudication	16	16
Vessel Or Plaque, Device Embedded In	16	16
Laceration(s)	15	24
Nerve Damage	14	14
Hypersensitivity/Allergic reaction	14	14
Loss Of Pulse	14	14
Thrombus	14	14
Cardiac Arrest	13	13
Hemostasis	12	12
Myocardial Infarction	12	12
Abscess	11	11
Local Reaction	11	11
Rupture	10	10
Discomfort	10	10
Post Operative Wound Infection	10	10
Fever	10	10
Unspecified Vascular Problem	10	10
Rash	9	9
Ecchymosis	9	9
Prolapse	9	9
Foreign Body Embolism	8	8
Dizziness	7	7
Hypovolemic Shock	7	7
Tachycardia	6	6
Skin Discoloration	6	6
Vascular System (Circulation), Impaired	6	6
Loss of consciousness	6	6
Injury	6	6
Cramp(s) /Muscle Spasm(s)	6	6
Patient Problem/Medical Problem	6	6
Thromboembolism	5	5
Multiple Organ Failure	5	5
Implant Pain	5	5
Skin Infection	5	5
Cardiogenic Shock	5	5
Discharge	5	5
Vasoconstriction	5	5
Chest Pain	5	5
Bacterial Infection	5	5
Bradycardia	5	5
Abdominal Pain	5	5
Arrhythmia	4	4
Cellulitis	4	4
Embolus	4	4
Erythema	4	4
High Blood Pressure/ Hypertension	4	4
Dyspnea	4	4
Fatigue	4	4
Weakness	4	4
Scar Tissue	4	4
Ambulation Difficulties	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Terumo Medical Corp	II	Jun-29-2018