TPLC - Total Product Life Cycle

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Device	balloon aortic valvuloplasty
Definition	A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Product Code	OZT
Regulation Number	870.1255
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	37	37
Material Rupture	28	28
Leak/Splash	11	11
Difficult to Remove	9	9
Inflation Problem	9	9
Break	8	8
Insufficient Information	7	7
Detachment of Device or Device Component	6	6
Retraction Problem	6	6
Deflation Problem	4	4
Material Puncture/Hole	4	4
Physical Resistance/Sticking	4	4
Difficult to Insert	3	3
Failure to Fold	3	3
Improper or Incorrect Procedure or Method	3	3
Output Problem	2	2
Packaging Problem	2	2
Device-Device Incompatibility	2	2
Material Perforation	2	2
Fracture	2	2
Entrapment of Device	2	2
Burst Container or Vessel	2	2
Peeled/Delaminated	2	2
Perivalvular Leak	2	2
Material Split, Cut or Torn	2	2
Unintended Deflation	1	1
Air/Gas in Device	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Flushing Problem	1	1
Device Damaged Prior to Use	1	1
Defective Device	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Difficult to Advance	1	1
Device Dislodged or Dislocated	1	1
Material Deformation	1	1
Positioning Problem	1	1
Unintended Movement	1	1
Suction Problem	1	1
Migration	1	1
Component Misassembled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	39	39
Rupture	14	14
Heart Block	9	9
Aortic Valve Insufficiency/ Regurgitation	8	8
Insufficient Information	8	8
Low Blood Pressure/ Hypotension	8	8
No Consequences Or Impact To Patient	7	7
No Patient Involvement	5	5
Pericardial Effusion	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Cardiac Perforation	4	4
Perforation	4	4
Hemorrhage/Bleeding	4	4
Cardiac Tamponade	3	3
Obstruction/Occlusion	3	3
Vascular Dissection	2	2
Device Embedded In Tissue or Plaque	2	2
Foreign Body In Patient	2	2
Aortic Insufficiency	2	2
Calcium Deposits/Calcification	2	2
Stroke/CVA	2	2
Death	2	2
Embolism	2	2
Laceration(s)	2	2
Tachycardia	2	2
Ventricular Fibrillation	2	2
Mitral Valve Insufficiency/ Regurgitation	2	2
Unspecified Tissue Injury	2	2
Cardiovascular Insufficiency	1	1
Valvular Insufficiency/ Regurgitation	1	1
Great Vessel Perforation	1	1
Dizziness	1	1
Mitral Regurgitation	1	1
Myocardial Infarction	1	1
Hematoma	1	1
Cardiac Arrest	1	1
High Blood Pressure/ Hypertension	1	1
No Known Impact Or Consequence To Patient	1	1
Cusp Tear	1	1
Unspecified Vascular Problem	1	1
Asystole	1	1
Low Cardiac Output	1	1
Injury	1	1
Renal Failure	1	1
Intimal Dissection	1	1