TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	738	740
Material Rupture	686	686
Material Puncture/Hole	300	300
Deflation Problem	203	203
Use of Device Problem	191	198
Fluid/Blood Leak	160	160
Leak/Splash	147	147
Fracture	135	135
Hole In Material	118	120
Crack	116	122
Break	82	82
Adverse Event Without Identified Device or Use Problem	78	78
Detachment Of Device Component	76	76
Difficult to Remove	67	67
Detachment of Device or Device Component	65	65
Material Deformation	59	59
Inflation Problem	52	52
Failure to Deflate	51	51
Off-Label Use	44	44
Material Twisted/Bent	44	44
Improper or Incorrect Procedure or Method	39	39
Material Fragmentation	34	34
Bent	25	25
Material Integrity Problem	18	18
Tear, Rip or Hole in Device Packaging	17	17
Material Separation	17	17
Delivered as Unsterile Product	10	10
Contamination /Decontamination Problem	10	10
Torn Material	9	9
Device-Device Incompatibility	8	8
Appropriate Term/Code Not Available	8	8
Unsealed Device Packaging	8	8
Deformation Due to Compressive Stress	7	7
Physical Resistance/Sticking	7	7
Entrapment of Device	7	7
Difficult to Advance	6	6
Failure to Advance	6	6
Retraction Problem	6	6
Kinked	5	5
Device Operates Differently Than Expected	5	5
Material Split, Cut or Torn	4	4
Packaging Problem	4	4
Defective Device	4	4
Loss of or Failure to Bond	4	4
Insufficient Information	4	4
Device Packaging Compromised	4	4
Device Dislodged or Dislocated	4	4
Device Damaged by Another Device	4	4
Material Perforation	4	4
Failure to Eject	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	1608	1618
No Clinical Signs, Symptoms or Conditions	1056	1056
No Known Impact Or Consequence To Patient	166	166
Foreign Body In Patient	48	48
No Patient Involvement	48	48
Device Embedded In Tissue or Plaque	27	27
Perforation	27	27
Insufficient Information	23	23
Perforation of Esophagus	18	18
Laceration(s) of Esophagus	14	14
Hemorrhage/Bleeding	11	11
No Information	11	11
No Code Available	8	8
Gastrointestinal Hemorrhage	6	6
Aspiration/Inhalation	6	6
Tissue Damage	4	4
Laceration(s)	4	4
Injury	4	4
Chest Pain	4	4
Death	3	3
Unspecified Tissue Injury	3	3
Intimal Dissection	2	2
Low Oxygen Saturation	2	2
Cough	2	2
Blood Loss	2	2
Pancreatitis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Abdominal Pain	2	2
Needle Stick/Puncture	1	1
Fever	1	1
Obstruction/Occlusion	1	1
Nerve Damage	1	1
Vomiting	1	1
Discomfort	1	1
Hemostasis	1	1
Pain	1	1
Abscess	1	1
Inflammation	1	1
Bowel Perforation	1	1
Perforation of Vessels	1	1
Anxiety	1	1
Unspecified Gastrointestinal Problem	1	1
Hypoxia	1	1
Pneumothorax	1	1
Patient Problem/Medical Problem	1	1
Fistula	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	III	Jul-10-2013