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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, steerable
Product CodeDRA
Regulation Number 870.1280
Device Class 2


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

MDR Year MDR Reports MDR Events
2019 700 700
2020 703 703
2021 741 778
2022 652 654
2023 787 787
2024 1247 1247

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1970 2009
Leak/Splash 1059 1059
Air/Gas in Device 438 438
Gas/Air Leak 327 327
Material Twisted/Bent 299 299
Material Integrity Problem 161 161
Deformation Due to Compressive Stress 132 132
Break 100 100
Failure to Advance 90 90
Device Contamination with Body Fluid 83 83
Material Split, Cut or Torn 82 82
Fluid/Blood Leak 81 81
Positioning Failure 81 81
Unintended Movement 76 76
Difficult to Insert 75 75
Compatibility Problem 67 67
Improper or Incorrect Procedure or Method 63 63
Difficult to Remove 61 61
Material Deformation 56 56
Difficult or Delayed Positioning 51 51
Difficult to Advance 50 50
Crack 35 35
Use of Device Problem 33 33
Off-Label Use 30 30
Noise, Audible 28 28
Material Separation 27 27
Unstable 25 25
Peeled/Delaminated 25 25
Device Handling Problem 22 22
Difficult to Flush 22 22
Physical Resistance/Sticking 22 22
Product Quality Problem 21 21
Device Contamination with Chemical or Other Material 21 21
Suction Problem 18 18
Mechanical Problem 15 15
Device-Device Incompatibility 14 14
Entrapment of Device 14 14
Detachment of Device or Device Component 13 13
Tear, Rip or Hole in Device Packaging 11 11
Appropriate Term/Code Not Available 9 9
Signal Artifact/Noise 8 8
Positioning Problem 8 8
Mechanical Jam 7 7
Insufficient Information 7 7
Activation, Positioning or Separation Problem 6 6
Device Markings/Labelling Problem 6 6
Device Damaged by Another Device 5 5
Packaging Problem 5 5
No Apparent Adverse Event 5 5
Loose or Intermittent Connection 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1926 1926
Pericardial Effusion 440 440
Low Blood Pressure/ Hypotension 385 385
Perforation 345 384
Cardiac Tamponade 302 302
No Consequences Or Impact To Patient 261 261
No Known Impact Or Consequence To Patient 236 236
Atrial Perforation 215 215
Air Embolism 181 181
Thrombosis/Thrombus 178 178
Hemorrhage/Bleeding 177 177
No Patient Involvement 150 150
Hematoma 144 144
Non specific EKG/ECG Changes 122 122
Cardiac Perforation 117 117
Thrombosis 84 84
Pseudoaneurysm 82 82
Fistula 77 77
Cardiac Arrest 69 69
Stroke/CVA 68 68
Hypoxia 60 60
Unspecified Tissue Injury 53 53
Arrhythmia 45 45
Perforation of Vessels 38 38
Tachycardia 38 38
Insufficient Information 38 38
Cardiovascular Insufficiency 34 34
Death 34 34
ST Segment Elevation 28 28
Bradycardia 27 27
Embolism/Embolus 27 27
Embolism 26 26
Vascular System (Circulation), Impaired 26 26
Chest Pain 26 26
Pain 24 24
Tissue Damage 22 22
Dyspnea 22 22
Heart Failure/Congestive Heart Failure 20 20
Transient Ischemic Attack 19 19
Vascular Dissection 18 18
Inflammation 18 18
High Blood Pressure/ Hypertension 18 18
Myocardial Infarction 17 17
No Code Available 17 17
Atrial Flutter 17 17
Heart Failure 17 17
Ventricular Fibrillation 15 15
Heart Block 15 15
Respiratory Distress 14 14
Paralysis 13 13

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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