TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
27	10	17	11	18	7

MDR Year	MDR Reports	MDR Events
2019	6156	6156
2020	5927	5927
2021	7586	7586
2022	9457	9466
2023	13529	13529
2024	4844	4844

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cycle	23538	23538
Material Separation	5326	5326
Malposition of Device	2270	2270
Improper or Incorrect Procedure or Method	2123	2123
Adverse Event Without Identified Device or Use Problem	1518	1518
Activation, Positioning or Separation Problem	1390	1390
Patient Device Interaction Problem	1371	1371
Insufficient Information	1366	1366
Off-Label Use	1363	1363
Entrapment of Device	1236	1236
Difficult to Open or Close	1160	1160
Difficult to Remove	1098	1098
Obstruction of Flow	1022	1022
Difficult to Insert	830	830
Physical Resistance/Sticking	705	705
Activation Failure	674	674
Decrease in Pressure	636	636
Mechanical Jam	629	629
Material Deformation	604	604
Detachment of Device or Device Component	604	604
Break	583	583
Material Rupture	533	533
Failure to Advance	529	529
Failure to Fire	508	508
Product Quality Problem	410	410
Difficult to Advance	407	407
Retraction Problem	337	337
Positioning Failure	324	324
Premature Activation	323	323
Deformation Due to Compressive Stress	307	307
Misconnection	287	287
Unintended System Motion	209	209
Activation Problem	166	166
Material Split, Cut or Torn	157	157
Migration	154	163
Positioning Problem	144	144
Difficult or Delayed Activation	141	141
Component Missing	138	138
Appropriate Term/Code Not Available	135	144
Device Damaged by Another Device	130	130
Separation Failure	120	120
Failure to Cut	114	114
Loosening of Implant Not Related to Bone-Ingrowth	112	112
Firing Problem	108	108
Failure to Seal	101	101
Noise, Audible	98	98
Material Twisted/Bent	95	95
Therapy Delivered to Incorrect Body Area	95	95
Unintended Movement	82	82
Use of Device Problem	80	89
Therapeutic or Diagnostic Output Failure	79	79
Inadequate or Insufficient Training	78	78
Deflation Problem	77	77
Defective Component	72	72
Burst Container or Vessel	70	70
Material Puncture/Hole	70	70
Migration or Expulsion of Device	60	60
Difficult or Delayed Positioning	56	56
Patient-Device Incompatibility	51	51
Defective Device	48	48
No Apparent Adverse Event	41	41
Material Frayed	40	40
Leak/Splash	33	33
Mechanical Problem	31	31
Expulsion	31	31
Fracture	29	29
Crack	29	29
Material Fragmentation	27	27
Component Misassembled	27	27
Difficult to Flush	26	26
Misfire	22	22
Accessory Incompatible	21	21
Loose or Intermittent Connection	20	20
Peeled/Delaminated	18	18
Separation Problem	16	16
Unsealed Device Packaging	15	15
Output Problem	14	14
Device Dislodged or Dislocated	13	13
Image Orientation Incorrect	11	11
Stretched	10	10
Contamination /Decontamination Problem	10	10
Material Integrity Problem	10	10
Material Disintegration	9	9
Failure to Deliver	8	8
Device Damaged Prior to Use	6	6
Loss of or Failure to Bond	6	6
Fluid/Blood Leak	5	5
Difficult to Open or Remove Packaging Material	5	5
Device Contamination with Chemical or Other Material	5	5
Connection Problem	5	5
Scratched Material	5	5
Difficult or Delayed Separation	5	5
Lack of Effect	4	4
Ejection Problem	4	4
Device Markings/Labelling Problem	4	4
Human-Device Interface Problem	3	3
No Flow	3	3
Packaging Problem	3	3
Inflation Problem	3	3
Failure to Capture	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	31634	31643
No Consequences Or Impact To Patient	9469	9469
Hemorrhage/Bleeding	1121	1121
Hematoma	932	941
Obstruction/Occlusion	703	703
Insufficient Information	637	637
Blood Loss	633	633
Unspecified Tissue Injury	536	536
Pseudoaneurysm	424	433
Foreign Body In Patient	394	394
Pain	387	387
Vascular Dissection	340	340
Tissue Damage	303	303
Extravasation	264	264
Occlusion	240	240
No Known Impact Or Consequence To Patient	185	185
Thrombosis/Thrombus	170	170
No Information	169	169
Stenosis	163	163
Unspecified Infection	135	135
Swelling/ Edema	116	116
Ischemia	114	114
Low Blood Pressure/ Hypotension	104	104
Intimal Dissection	104	104
Perforation of Vessels	97	97
Thrombosis	77	77
No Patient Involvement	76	76
Diminished Pulse Pressure	71	71
Death	62	62
Device Embedded In Tissue or Plaque	60	60
No Code Available	59	59
Retroperitoneal Hemorrhage	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	63
Failure of Implant	48	48
Perforation	48	48
Fistula	46	46
Numbness	44	44
Embolism/Embolus	44	44
Inflammation	41	41
Anemia	38	38
Laceration(s)	37	46
Unspecified Vascular Problem	36	36
Bruise/Contusion	33	33
Stroke/CVA	32	32
Shock	25	25
Renal Failure	23	23
Embolism	22	22
Swelling	22	22
Calcium Deposits/Calcification	19	19
Cardiac Arrest	18	18
Aneurysm	17	17
Sepsis	17	17
Nerve Damage	15	15
Vessel Or Plaque, Device Embedded In	14	14
Discomfort	14	14
Claudication	14	14
Myocardial Infarction	13	13
Local Reaction	13	13
Fever	12	12
Hemostasis	11	11
Abscess	11	11
Post Operative Wound Infection	11	11
Foreign Body Embolism	11	11
Thromboembolism	10	10
Loss Of Pulse	10	10
Hypersensitivity/Allergic reaction	10	10
Thrombus	9	9
Rupture	9	9
Dizziness	9	9
Implant Pain	9	9
Skin Discoloration	8	8
Ambulation Difficulties	8	8
High Blood Pressure/ Hypertension	8	8
Fatigue	8	8
Rash	8	8
Hypovolemic Shock	7	7
Hypoxia	7	7
Ecchymosis	7	7
Loss of consciousness	7	7
Cramp(s) /Muscle Spasm(s)	7	7
Syncope/Fainting	6	6
Prolapse	6	6
Vasoconstriction	6	6
Cardiogenic Shock	6	6
Chest Pain	6	6
Pulmonary Embolism	6	6
Bradycardia	6	6
Nausea	6	6
Abdominal Pain	5	5
Arrhythmia	5	5
Chills	5	5
Injury	5	5
Patient Problem/Medical Problem	5	5
Skin Infection	5	5
Easy Bruising	4	4
Test Result	4	4
Multiple Organ Failure	4	4
Unspecified Heart Problem	4	4
Transient Ischemic Attack	4	4
Weakness	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Cordis US Corp	II	Jan-05-2024
2	TELEFLEX LLC	II	May-18-2023