TPLC - Total Product Life Cycle

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Device	percutaneous catheter, ultrasound
Regulation Description	Percutaneous catheter.
Definition	Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.
Product Code	PPN
Regulation Number	870.1250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	101	101
Difficult to Remove	55	55
Material Split, Cut or Torn	50	50
Adverse Event Without Identified Device or Use Problem	44	44
Material Separation	31	31
Off-Label Use	20	20
Material Rupture	16	16
Difficult to Advance	6	6
Entrapment of Device	5	5
Deflation Problem	4	4
Failure to Deflate	3	3
Improper or Incorrect Procedure or Method	3	3
Device-Device Incompatibility	2	2
Material Puncture/Hole	2	2
Material Fragmentation	2	2
Stretched	2	2
Device Handling Problem	2	2
Retraction Problem	2	2
No Apparent Adverse Event	2	2
Deformation Due to Compressive Stress	2	2
Leak/Splash	1	1
Break	1	1
Output Problem	1	1
Material Integrity Problem	1	1
Use of Device Problem	1	1
Insufficient Device Problem Information	1	1
Device Damaged by Another Device	1	1
Inflation Problem	1	1
Delivered as Unsterile Product	1	1
Packaging Problem	1	1
Failure to Cycle	1	1
Nonstandard Device	1	1
Connection Problem	1	1
Human-Device Interface Problem	1	1
Intermittent Communication Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	122	122
Foreign Body In Patient	20	20
Perforation of Vessels	14	14
Insufficient Information	11	11
Vascular Dissection	10	10
Hemorrhage/Blood Loss/Bleeding	10	10
Hematoma	7	7
Perforation	7	7
Peripheral Vascular Disease	7	7
Low Blood Pressure/ Hypotension	7	7
Embolism/Embolus	5	5
Obstruction/Occlusion	4	4
Cardiac Arrest	4	4
Pain	4	4
Restenosis	3	3
Device Embedded In Tissue or Plaque	3	3
No Known Impact Or Consequence To Patient	3	3
Retroperitoneal Hemorrhage	3	3
Swelling/ Edema	3	3
Reduced Blood Flow	2	2
Ischemia	2	2
Mitral Perforation	2	2
Hemorrhagic Stroke	2	2
Myocardial Infarction	2	2
Tachycardia	2	2
Foreign Body Embolism	2	2
Renal Failure	2	2
Low Oxygen Saturation	1	1
Spinal Cord Injury	1	1
Hemothorax	1	1
Thromboembolism	1	1
No Consequences Or Impact To Patient	1	1
Pseudoaneurysm	1	1
Embolism	1	1
Coronary obstruction/occlusion	1	1
Shock	1	1
Extravasation	1	1
Bradycardia	1	1
Paresis	1	1
Discomfort	1	1
Cardiogenic Shock	1	1
Viral Infection	1	1
Thrombosis/Thrombus	1	1
Paralysis	1	1
Fever	1	1
Post Operative Wound Infection	1	1
Cardiac Tamponade	1	1
Transient Ischemic Attack	1	1
Rupture	1	1
Atrial Fibrillation	1	1