TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
GREATBATCH MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
OSCOR INC.
	SUBSTANTIALLY EQUIVALENT	1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
	SUBSTANTIALLY EQUIVALENT	5
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
	SUBSTANTIALLY EQUIVALENT	2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SYNAPTIC MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SYNAPTIC MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	529	529
Break	95	95
Insufficient Information	33	33
Activation, Positioning or Separation Problem	32	32
Difficult to Insert	28	28
Fracture	23	23
Gas/Air Leak	10	10
Material Separation	10	10
Detachment of Device or Device Component	10	10
Unintended Movement	9	9
Material Twisted/Bent	8	8
Appropriate Term/Code Not Available	7	7
Detachment Of Device Component	7	7
Device Contamination with Chemical or Other Material	6	6
Inflation Problem	5	5
Bent	5	5
Use of Device Problem	5	5
Device Operates Differently Than Expected	5	5
Contamination /Decontamination Problem	5	5
Device Contamination with Body Fluid	5	5
Positioning Problem	5	5
Material Fragmentation	4	4
Physical Resistance/Sticking	4	4
Difficult to Advance	4	4
Corroded	3	3
Improper or Incorrect Procedure or Method	3	3
Component Missing	3	3
Patient Device Interaction Problem	3	3
Difficult to Remove	3	3
No Apparent Adverse Event	3	3
Physical Resistance	3	3
Mechanical Problem	3	3
Leak/Splash	3	3
Defective Device	2	2
Loose or Intermittent Connection	2	2
Material Puncture/Hole	2	2
Entrapment of Device	2	2
Failure to Advance	2	2
Malposition of Device	2	2
Unexpected Therapeutic Results	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Protrusion/Extrusion	2	2
Device Contaminated During Manufacture or Shipping	2	2
Scratched Material	2	2
Failure to Disconnect	1	1
Flaked	1	1
Packaging Problem	1	1
Material Rupture	1	1
Positioning Failure	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cardiac Perforation	425	425
No Clinical Signs, Symptoms or Conditions	100	100
No Known Impact Or Consequence To Patient	86	86
Pericardial Effusion	84	84
Low Blood Pressure/ Hypotension	43	43
Cardiac Tamponade	40	40
No Consequences Or Impact To Patient	32	32
Death	24	24
Perforation	16	16
Stroke/CVA	15	15
No Patient Involvement	14	14
Great Vessel Perforation	11	11
Hemorrhage/Bleeding	9	9
Thrombosis/Thrombus	8	8
Foreign Body In Patient	7	7
Air Embolism	6	6
Device Embedded In Tissue or Plaque	6	6
Arrhythmia	6	6
No Code Available	6	6
Vascular Dissection	6	6
Cardiac Arrest	6	6
Insufficient Information	5	5
No Information	5	5
Hematoma	4	4
Transient Ischemic Attack	4	4
Perforation of Vessels	3	3
Pseudoaneurysm	3	3
Chest Pain	3	3
Needle Stick/Puncture	3	3
Hemothorax	3	3
Thrombus	3	3
Patient Problem/Medical Problem	3	3
Aortic Dissection	2	2
Discomfort	2	2
Embolus	2	2
Pain	2	2
Non specific EKG/ECG Changes	2	2
Tachycardia	2	2
Extubate	1	1
Atrial Perforation	1	1
Unspecified Vascular Problem	1	1
Respiratory Failure	1	1
Hypoxia	1	1
ST Segment Elevation	1	1
Low Oxygen Saturation	1	1
Myocardial Infarction	1	1
Unspecified Tissue Injury	1	1
Pulmonary Edema	1	1
Fistula	1	1
Extravasation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Nov-13-2021
2	Cook Inc.	I	Mar-13-2019
3	Cook Incorporated	II	Apr-12-2024
4	CooperSurgical, Inc.	II	May-01-2018
5	CooperSurgical, Inc. D.B.A. Lone Star Medical Products	II	Oct-29-2014
6	Ethicon Endo-Surgery Inc	II	Jun-26-2015
7	Instrumed International, Inc.	II	Dec-16-2014
8	Medical Device Technologies, Inc.	II	Jul-13-2010
9	Merit Medical Systems, Inc.	II	Mar-16-2021
10	Merit Medical Systems, Inc.	II	Apr-12-2016