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	10

MDR Year	MDR Reports	MDR Events
2019	6156	6156
2020	5927	5927
2021	7586	7586
2022	9457	9466
2023	13529	13529
2024	7057	7057

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cycle	24819	24819
Material Separation	5605	5605
Malposition of Device	2331	2331
Improper or Incorrect Procedure or Method	2194	2194
Adverse Event Without Identified Device or Use Problem	1549	1549
Insufficient Information	1452	1452
Off-Label Use	1413	1413
Patient Device Interaction Problem	1412	1412
Activation, Positioning or Separation Problem	1404	1404
Entrapment of Device	1277	1277
Difficult to Open or Close	1218	1218
Difficult to Remove	1125	1125
Obstruction of Flow	1049	1049
Difficult to Insert	845	845
Physical Resistance/Sticking	718	718
Activation Failure	696	696
Decrease in Pressure	665	665
Mechanical Jam	643	643
Material Deformation	611	611
Detachment of Device or Device Component	607	607
Break	589	589
Material Rupture	562	562
Failure to Advance	555	555
Failure to Fire	536	536
Difficult to Advance	424	424
Product Quality Problem	422	422
Premature Activation	388	388
Retraction Problem	341	341
Positioning Failure	327	327
Deformation Due to Compressive Stress	312	312
Misconnection	287	287
Unintended System Motion	214	214
Migration	177	186
Activation Problem	173	173
Material Split, Cut or Torn	163	163
Difficult or Delayed Activation	148	148
Positioning Problem	147	147
Loosening of Implant Not Related to Bone-Ingrowth	139	139
Component Missing	139	139
Device Damaged by Another Device	137	137
Appropriate Term/Code Not Available	135	144
Separation Failure	120	120
Failure to Cut	116	116
Failure to Seal	113	113
Firing Problem	109	109
Noise, Audible	106	106
Therapy Delivered to Incorrect Body Area	96	96
Material Twisted/Bent	95	95
Use of Device Problem	84	93
Unintended Movement	83	83
Material Puncture/Hole	80	80
Therapeutic or Diagnostic Output Failure	79	79
Inadequate or Insufficient Training	78	78
Deflation Problem	77	77
Defective Component	73	73
Burst Container or Vessel	70	70
Migration or Expulsion of Device	60	60
Difficult or Delayed Positioning	58	58
Patient-Device Incompatibility	51	51
Defective Device	48	48
Material Frayed	43	43
No Apparent Adverse Event	42	42
Leak/Splash	33	33
Crack	32	32
Mechanical Problem	31	31
Expulsion	31	31
Fracture	30	30
Image Orientation Incorrect	28	28
Difficult to Flush	28	28
Material Fragmentation	27	27
Component Misassembled	27	27
Misfire	23	23
Accessory Incompatible	21	21
Loose or Intermittent Connection	20	20
Peeled/Delaminated	20	20
Separation Problem	16	16
Unsealed Device Packaging	15	15
Output Problem	14	14
Device Dislodged or Dislocated	13	13
Contamination /Decontamination Problem	10	10
Material Integrity Problem	10	10
Stretched	10	10
Material Disintegration	10	10
Failure to Deliver	8	8
Device Damaged Prior to Use	6	6
Loss of or Failure to Bond	6	6
Device Contamination with Chemical or Other Material	6	6
Difficult to Open or Remove Packaging Material	5	5
Connection Problem	5	5
Scratched Material	5	5
Difficult or Delayed Separation	5	5
Fluid/Blood Leak	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
Delivered as Unsterile Product	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	33646	33655
No Consequences Or Impact To Patient	9469	9469
Hemorrhage/Bleeding	1177	1177
Hematoma	962	971
Obstruction/Occlusion	734	734
Insufficient Information	662	662
Blood Loss	633	633
Unspecified Tissue Injury	569	569
Pseudoaneurysm	449	458
Foreign Body In Patient	406	406
Pain	397	397
Vascular Dissection	351	351
Tissue Damage	303	303
Extravasation	268	268
Occlusion	240	240
No Known Impact Or Consequence To Patient	185	185
Thrombosis/Thrombus	175	175
No Information	169	169
Stenosis	166	166
Unspecified Infection	144	144
Swelling/ Edema	121	121
Ischemia	118	118
Low Blood Pressure/ Hypotension	108	108
Perforation of Vessels	106	106
Intimal Dissection	104	104
Thrombosis	77	77
No Patient Involvement	76	76
Diminished Pulse Pressure	74	74
Death	62	62
Device Embedded In Tissue or Plaque	60	60
No Code Available	59	59
Retroperitoneal Hemorrhage	59	59
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	54	63
Failure of Implant	54	54
Perforation	48	48
Fistula	47	47
Embolism/Embolus	46	46
Numbness	44	44
Inflammation	43	43
Anemia	41	41
Laceration(s)	39	48
Unspecified Vascular Problem	39	39
Stroke/CVA	34	34
Bruise/Contusion	33	33
Shock	26	26
Renal Failure	24	24
Embolism	22	22
Swelling	22	22
Calcium Deposits/Calcification	19	19
Cardiac Arrest	18	18
Aneurysm	17	17
Sepsis	17	17
Nerve Damage	16	16
Discomfort	15	15
Claudication	14	14
Vessel Or Plaque, Device Embedded In	14	14
Myocardial Infarction	13	13
Local Reaction	13	13
Fever	13	13
Post Operative Wound Infection	12	12
Hemostasis	11	11
Hypersensitivity/Allergic reaction	11	11
Abscess	11	11
Foreign Body Embolism	11	11
Thromboembolism	10	10
Loss Of Pulse	10	10
Skin Discoloration	9	9
Thrombus	9	9
Rupture	9	9
Dizziness	9	9
High Blood Pressure/ Hypertension	9	9
Fatigue	9	9
Implant Pain	9	9
Rash	8	8
Ambulation Difficulties	8	8
Loss of consciousness	7	7
Prolapse	7	7
Cardiogenic Shock	7	7
Hypovolemic Shock	7	7
Hypoxia	7	7
Ecchymosis	7	7
Cramp(s) /Muscle Spasm(s)	7	7
Syncope/Fainting	6	6
Chest Pain	6	6
Pulmonary Embolism	6	6
Bradycardia	6	6
Nausea	6	6
Vasoconstriction	6	6
Chills	5	5
Injury	5	5
Abdominal Pain	5	5
Arrhythmia	5	5
Patient Problem/Medical Problem	5	5
Unspecified Heart Problem	5	5
Skin Infection	5	5
Easy Bruising	4	4
Test Result	4	4
Multiple Organ Failure	4	4
Bacterial Infection	4	4
Dyspnea	4	4

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