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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device dilator, vessel, 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
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDRON, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2019 144 144
2020 120 120
2021 115 1579
2022 136 136
2023 392 392
2024 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 374 1106
Fracture 139 139
Material Separation 98 98
Detachment of Device or Device Component 98 98
Physical Resistance/Sticking 97 219
Device-Device Incompatibility 77 77
Difficult to Remove 76 76
Break 61 183
Material Deformation 44 44
Device Contamination with Chemical or Other Material 43 43
Difficult to Advance 39 39
Defective Device 34 34
Entrapment of Device 33 33
Positioning Problem 27 27
Material Integrity Problem 22 22
Manufacturing, Packaging or Shipping Problem 14 14
Mechanical Jam 13 379
Component or Accessory Incompatibility 9 9
Unraveled Material 9 9
Material Frayed 8 8
Sharp Edges 8 8
Material Twisted/Bent 7 7
Device Damaged by Another Device 7 7
Loss of or Failure to Bond 7 7
Use of Device Problem 7 7
Material Fragmentation 7 7
Device Dislodged or Dislocated 6 6
Failure to Advance 6 6
Material Split, Cut or Torn 6 6
Failure to Cut 5 127
Deformation Due to Compressive Stress 5 5
Migration 5 5
Device Contaminated During Manufacture or Shipping 4 4
Retraction Problem 4 4
Tear, Rip or Hole in Device Packaging 4 4
Crack 4 4
Difficult to Insert 4 4
Fluid/Blood Leak 4 4
Difficult to Open or Remove Packaging Material 3 3
Component Missing 3 3
Insufficient Information 3 3
Mechanics Altered 3 125
Stretched 2 2
Device Markings/Labelling Problem 2 2
Human-Device Interface Problem 2 2
Material Disintegration 2 2
Leak/Splash 2 2
Partial Blockage 2 2
Calcified 2 2
Migration or Expulsion of Device 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Material Perforation 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Complete Blockage 1 1
Contamination 1 1
Disconnection 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Display or Visual Feedback Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 902
Foreign Body In Patient 127 249
Pericardial Effusion 121 365
Great Vessel Perforation 86 330
Low Blood Pressure/ Hypotension 81 81
Perforation of Vessels 74 684
No Consequences Or Impact To Patient 69 69
Thrombosis/Thrombus 50 50
Cardiac Tamponade 47 47
Iatrogenic Source 47 169
Cardiac Perforation 46 46
Device Embedded In Tissue or Plaque 39 39
No Known Impact Or Consequence To Patient 35 35
Hemorrhage/Bleeding 28 28
Death 21 143
Hematoma 20 20
Insufficient Information 20 20
Perforation 18 18
Embolism 17 17
Cardiac Arrest 11 11
Air Embolism 10 10
Atrial Perforation 10 10
Arrhythmia 8 8
Laceration(s) 8 8
Vascular Dissection 8 8
No Patient Involvement 8 8
Non specific EKG/ECG Changes 6 6
Pain 5 5
Pleural Effusion 5 5
No Code Available 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Asystole 4 4
Ventricular Fibrillation 4 4
Vasoconstriction 3 3
Pneumothorax 3 3
Hypoxia 3 3
Pulmonary Embolism 3 3
Heart Block 3 3
Thromboembolism 3 3
Cusp Tear 2 2
Patient Problem/Medical Problem 2 2
Foreign Body Embolism 2 2
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Retroperitoneal Hemorrhage 2 2
Fistula 2 2
Calcium Deposits/Calcification 2 2
Chest Pain 2 2
High Blood Pressure/ Hypertension 2 2
Ischemia 2 2
Hemothorax 2 2
Sepsis 2 2
Tachycardia 2 2
Vomiting 2 2
Pseudoaneurysm 2 2
Electric Shock 2 2
Injury 2 2
Obstruction/Occlusion 2 2
Post Operative Wound Infection 1 1
Paraplegia 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Peritonitis 1 1
Stenosis 1 1
Rupture 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Tingling 1 1
Peripheral Vascular Disease 1 1
Thrombosis 1 1
Tissue Damage 1 1
Tricuspid Regurgitation 1 1
Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Hypovolemic Shock 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Paralysis 1 1
Myocardial Infarction 1 1
Internal Organ Perforation 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Dyspnea 1 1
Foreign Body Reaction 1 1
Extravasation 1 1
Adhesion(s) 1 1
Stroke/CVA 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Swelling/ Edema 1 1
Unspecified Respiratory Problem 1 1
Cough 1 1
Low White Blood Cell Count 1 1
Ruptured Aneurysm 1 1
Unspecified Vascular Problem 1 1
No Information 1 1

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
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