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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 4
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 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 380 1112
Fracture 142 142
Material Separation 100 100
Detachment of Device or Device Component 100 100
Physical Resistance/Sticking 97 219
Device-Device Incompatibility 77 77
Difficult to Remove 76 76
Break 61 183
Material Deformation 45 45
Device Contamination with Chemical or Other Material 43 43
Difficult to Advance 41 41
Defective Device 36 36
Entrapment of Device 33 33
Positioning Problem 28 28
Material Integrity Problem 22 22
Manufacturing, Packaging or Shipping Problem 14 14
Mechanical Jam 13 379
Component or Accessory Incompatibility 9 9
Material Frayed 9 9
Unraveled Material 9 9
Sharp Edges 8 8
Material Twisted/Bent 7 7
Device Damaged by Another Device 7 7
Use of Device Problem 7 7
Material Fragmentation 7 7
Loss of or Failure to Bond 7 7
Material Split, Cut or Torn 7 7
Failure to Advance 6 6
Device Dislodged or Dislocated 6 6
Failure to Cut 5 127
Deformation Due to Compressive Stress 5 5
Migration 5 5
Tear, Rip or Hole in Device Packaging 4 4
Device Contaminated During Manufacture or Shipping 4 4
Insufficient Information 4 4
Crack 4 4
Difficult to Insert 4 4
Fluid/Blood Leak 4 4
Retraction Problem 4 4
Component Missing 3 3
Mechanics Altered 3 125
Difficult to Open or Remove Packaging Material 3 3
Human-Device Interface Problem 2 2
Device Markings/Labelling Problem 2 2
Stretched 2 2
Material Perforation 2 2
Migration or Expulsion of Device 2 2
Unsealed Device Packaging 2 2
Material Disintegration 2 2
Display or Visual Feedback Problem 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
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
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Packaging Problem 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
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 300 910
Foreign Body In Patient 130 252
Pericardial Effusion 128 372
Great Vessel Perforation 89 333
Low Blood Pressure/ Hypotension 85 85
Perforation of Vessels 75 685
No Consequences Or Impact To Patient 69 69
Cardiac Perforation 51 51
Thrombosis/Thrombus 50 50
Cardiac Tamponade 49 49
Iatrogenic Source 47 169
Device Embedded In Tissue or Plaque 39 39
No Known Impact Or Consequence To Patient 35 35
Hemorrhage/Bleeding 29 29
Death 21 143
Insufficient Information 21 21
Hematoma 20 20
Perforation 18 18
Embolism 17 17
Cardiac Arrest 11 11
Air Embolism 10 10
Atrial Perforation 10 10
Laceration(s) 9 9
Vascular Dissection 9 9
No Patient Involvement 8 8
Arrhythmia 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
Tachycardia 2 2
Sepsis 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
Shock 1 1
Thrombosis 1 1
Tissue Damage 1 1
Tricuspid Regurgitation 1 1
Pulmonary Edema 1 1
Peripheral Vascular Disease 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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