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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
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 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 362 1094
Fracture 138 138
Material Separation 96 96
Physical Resistance/Sticking 96 218
Detachment of Device or Device Component 95 95
Device-Device Incompatibility 76 76
Difficult to Remove 76 76
Break 60 182
Device Contamination with Chemical or Other Material 43 43
Material Deformation 42 42
Difficult to Advance 35 35
Defective Device 34 34
Entrapment of Device 32 32
Material Integrity Problem 22 22
Positioning Problem 18 18
Manufacturing, Packaging or Shipping Problem 14 14
Mechanical Jam 13 379
Component or Accessory Incompatibility 9 9
Unraveled Material 9 9
Sharp Edges 8 8
Device Damaged by Another Device 7 7
Material Twisted/Bent 7 7
Use of Device Problem 7 7
Material Fragmentation 7 7
Material Frayed 7 7
Loss of or Failure to Bond 7 7
Device Dislodged or Dislocated 6 6
Failure to Advance 6 6
Material Split, Cut or Torn 6 6
Migration 5 5
Failure to Cut 5 127
Deformation Due to Compressive Stress 5 5
Device Contaminated During Manufacture or Shipping 4 4
Crack 4 4
Difficult to Insert 4 4
Fluid/Blood Leak 4 4
Tear, Rip or Hole in Device Packaging 4 4
Retraction Problem 4 4
Component Missing 3 3
Difficult to Open or Remove Packaging Material 3 3
Mechanics Altered 3 125
Insufficient Information 3 3
Human-Device Interface Problem 2 2
Device Markings/Labelling Problem 2 2
Stretched 2 2
Migration or Expulsion of Device 2 2
Unsealed Device Packaging 2 2
Material Disintegration 2 2
Leak/Splash 2 2
Partial Blockage 2 2
Calcified 2 2
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
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Shipping Damage or Problem 1 1
Device Slipped 1 1
Material Perforation 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Packaging 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 289 899
Foreign Body In Patient 122 244
Pericardial Effusion 108 352
Great Vessel Perforation 83 327
Perforation of Vessels 71 681
Low Blood Pressure/ Hypotension 71 71
No Consequences Or Impact To Patient 69 69
Thrombosis/Thrombus 49 49
Iatrogenic Source 47 169
Cardiac Tamponade 44 44
Cardiac Perforation 43 43
Device Embedded In Tissue or Plaque 39 39
No Known Impact Or Consequence To Patient 35 35
Hemorrhage/Bleeding 28 28
Death 21 143
Insufficient Information 20 20
Hematoma 18 18
Embolism 17 17
Perforation 17 17
Cardiac Arrest 11 11
Atrial Perforation 10 10
Air Embolism 9 9
Laceration(s) 8 8
No Patient Involvement 8 8
Vascular Dissection 8 8
Arrhythmia 7 7
Non specific EKG/ECG Changes 6 6
Pain 5 5
No Code Available 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Ventricular Fibrillation 4 4
Asystole 4 4
Pleural Effusion 4 4
Pneumothorax 3 3
Hypoxia 3 3
Pulmonary Embolism 3 3
Thromboembolism 3 3
Vasoconstriction 3 3
Heart Block 3 3
Respiratory Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Foreign Body Embolism 2 2
Ischemia 2 2
Tachycardia 2 2
Cusp Tear 2 2
Patient Problem/Medical Problem 2 2
Pseudoaneurysm 2 2
Electric Shock 2 2
Injury 2 2
Obstruction/Occlusion 2 2
Fistula 2 2
Calcium Deposits/Calcification 2 2
Chest Pain 2 2
High Blood Pressure/ Hypertension 2 2
Hemothorax 2 2
Hypersensitivity/Allergic reaction 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Sepsis 1 1
Shock 1 1
Paralysis 1 1
Myocardial Infarction 1 1
Internal Organ Perforation 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Dyspnea 1 1
Extravasation 1 1
Adhesion(s) 1 1
Stroke/CVA 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Post Operative Wound Infection 1 1
Paraplegia 1 1
Diaphoresis 1 1
Low Oxygen Saturation 1 1
Respiratory Failure 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Diminished Pulse Pressure 1 1
Thrombosis 1 1
Tissue Damage 1 1
Tricuspid Regurgitation 1 1
Peripheral Vascular Disease 1 1
Peritonitis 1 1
Stenosis 1 1
Rupture 1 1
Vomiting 1 1
Tingling 1 1
Cough 1 1
Unspecified Respiratory Problem 1 1
Retroperitoneal Hemorrhage 1 1
Swelling/ Edema 1 1
Unspecified Vascular Problem 1 1
Ruptured Aneurysm 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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