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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, steerable
Regulation Description Steerable catheter.
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KARDIUM INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 703 703
2021 741 778
2022 652 654
2023 788 788
2024 1966 1966
2025 2142 2142

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2275 2314
Air/Gas in Device 1615 1615
Leak/Splash 1502 1502
Material Twisted/Bent 442 442
Material Integrity Problem 355 355
Gas/Air Leak 349 349
Device Contamination with Body Fluid 224 224
Deformation Due to Compressive Stress 141 141
Break 116 116
Difficult to Advance 110 110
Failure to Advance 98 98
Compatibility Problem 88 88
Unintended Movement 88 88
Positioning Failure 85 85
Difficult to Insert 82 82
Material Split, Cut or Torn 76 76
Difficult to Remove 75 75
Suction Problem 71 71
Difficult to Flush 66 66
Material Deformation 62 62
Use of Device Problem 60 60
Improper or Incorrect Procedure or Method 57 57
Fluid/Blood Leak 56 56
Crack 56 56
Difficult or Delayed Positioning 49 49
Device-Device Incompatibility 45 45
Device Contamination with Chemical or Other Material 38 38
Off-Label Use 37 37
Device Handling Problem 34 34
Physical Resistance/Sticking 32 32
Peeled/Delaminated 31 31
Noise, Audible 30 30
Detachment of Device or Device Component 28 28
Unstable 27 27
Product Quality Problem 26 26
Material Separation 25 25
Mechanical Problem 25 25
Positioning Problem 19 19
Entrapment of Device 16 16
Improper Flow or Infusion 13 13
Material Perforation 11 11
Tear, Rip or Hole in Device Packaging 11 11
Packaging Problem 10 10
Signal Artifact/Noise 9 9
Flushing Problem 8 8
Insufficient Information 8 8
Mechanical Jam 8 8
Appropriate Term/Code Not Available 7 7
Loose or Intermittent Connection 7 7
Unsealed Device Packaging 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4140 4140
Pericardial Effusion 485 485
Low Blood Pressure/ Hypotension 476 476
Perforation 414 453
Cardiac Tamponade 341 341
Thrombosis/Thrombus 254 254
Air Embolism 245 245
Non specific EKG/ECG Changes 205 205
Hemorrhage/Bleeding 189 189
No Consequences Or Impact To Patient 180 180
Hematoma 133 133
Atrial Perforation 133 133
Cardiac Perforation 127 127
Cardiac Arrest 95 95
Stroke/CVA 90 90
Pseudoaneurysm 81 81
No Patient Involvement 80 80
No Known Impact Or Consequence To Patient 79 79
Fistula 71 71
Hypoxia 69 69
Unspecified Tissue Injury 65 65
Perforation of Vessels 58 58
Tachycardia 51 51
Thrombosis 49 49
Arrhythmia 47 47
Insufficient Information 44 44
Bradycardia 36 36
Cardiovascular Insufficiency 36 36
Embolism/Embolus 34 34
Vascular Dissection 27 27
Heart Failure/Congestive Heart Failure 27 27
Pain 25 25
Ventricular Fibrillation 24 24
Chest Pain 24 24
Dyspnea 24 24
Myocardial Infarction 22 22
Transient Ischemic Attack 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Atrial Flutter 20 20
Atrial Fibrillation 19 19
Heart Block 19 19
High Blood Pressure/ Hypertension 18 18
ST Segment Elevation 18 18
Death 17 17
Embolism 16 16
Inflammation 16 16
Paralysis 14 14
Cardiogenic Shock 13 13
Heart Failure 12 12
Respiratory Distress 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Mar-26-2024
2 Medtronic Perfusion Systems II Sep-22-2021
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