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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, vessel, for percutaneous catheterization
Regulation Description Vessel dilator for percutaneous catheterization.
Product CodeDRE
Regulation Number 870.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MEDRON, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XCARDIA INNOVATION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 120 120
2021 115 1579
2022 136 136
2023 392 392
2024 325 325
2025 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 399 1131
Fracture 133 133
Detachment of Device or Device Component 99 99
Material Separation 97 97
Physical Resistance/Sticking 96 218
Device-Device Incompatibility 83 83
Difficult to Remove 74 74
Defective Device 66 66
Positioning Problem 55 55
Break 55 177
Material Deformation 50 50
Difficult to Advance 50 50
Entrapment of Device 32 32
Material Integrity Problem 23 23
Material Perforation 18 18
Device Contamination with Chemical or Other Material 16 16
Unraveled Material 11 11
Material Frayed 10 10
Component or Accessory Incompatibility 9 9
Display or Visual Feedback Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Material Split, Cut or Torn 8 8
Sharp Edges 8 8
Mechanical Jam 7 373
Loss of or Failure to Bond 7 7
Material Twisted/Bent 7 7
Use of Device Problem 6 6
Failure to Advance 6 6
Fluid/Blood Leak 6 6
Device Damaged by Another Device 6 6
Failure to Cut 5 127
Material Fragmentation 5 5
Deformation Due to Compressive Stress 5 5
Device Dislodged or Dislocated 5 5
Insufficient Information 5 5
Migration 4 4
Difficult to Insert 4 4
Unsealed Device Packaging 4 4
Crack 4 4
Device Contaminated During Manufacture or Shipping 4 4
Tear, Rip or Hole in Device Packaging 4 4
Leak/Splash 4 4
Mechanics Altered 3 125
Partial Blockage 3 3
Mechanical Problem 3 3
Unintended Movement 3 3
Retraction Problem 3 3
Component Missing 3 3
Difficult to Open or Remove Packaging Material 3 3
Separation Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 383 993
Pericardial Effusion 164 408
Foreign Body In Patient 126 248
Low Blood Pressure/ Hypotension 108 108
Great Vessel Perforation 94 338
Perforation of Vessels 79 689
Cardiac Perforation 74 74
Cardiac Tamponade 68 68
Thrombosis/Thrombus 63 63
Hemorrhage/Bleeding 33 33
Device Embedded In Tissue or Plaque 32 32
No Consequences Or Impact To Patient 29 29
Iatrogenic Source 26 148
Insufficient Information 24 24
No Known Impact Or Consequence To Patient 22 22
Hematoma 19 19
Perforation 18 18
Air Embolism 17 17
Cardiac Arrest 16 16
Death 13 135
Non specific EKG/ECG Changes 12 12
Laceration(s) 11 11
Arrhythmia 10 10
Vascular Dissection 10 10
Bradycardia 8 8
Atrial Perforation 7 7
Pain 7 7
Pleural Effusion 6 6
Retroperitoneal Hemorrhage 6 6
Heart Block 6 6
Asystole 6 6
Tachycardia 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Ischemia 4 4
Myocardial Infarction 4 4
Pneumothorax 4 4
Stroke/CVA 3 3
Pulmonary Embolism 3 3
Thromboembolism 3 3
No Patient Involvement 3 3
Pseudoaneurysm 3 3
Ventricular Fibrillation 3 3
Vasoconstriction 3 3
High Blood Pressure/ Hypertension 3 3
Hypoxia 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Diminished Pulse Pressure 2 2
Cusp Tear 2 2
Rupture 2 2
Hemothorax 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Mar-21-2024
2 Argon Medical Devices, Inc II Aug-14-2020
3 Cardiac Assist, Inc II Apr-23-2021
4 Cordis Corporation II Jul-15-2021
5 Maquet Cardiovascular Us Sales, Llc II Mar-27-2020
6 Merit Medical Systems, Inc. II Sep-20-2024
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